FDA 483 - Stryker Corporation - May 14, 2009

The FDA Form 483 inspection of Stryker Instruments revealed multiple violations related to quality systems and manufacturing processes for various medical devices, including Clover Catheters, Silver Ex-Fen Catheters, Stryker Auto-Fuser PainPumps, and other surgical instruments.

**Key Violations and Observations:**

* **Inadequate Process Validation:** * **Clover and Silver Ex-Fen Catheters:** The injection molding process for the female luer hub was not fully validated. Validation runs showed dimensional failures, short shots, flash, and contamination, but were not repeated with revised parameters. Nominal runs were not representative of routine production duration. The extrusion process for tubing was also not validated, with only outer diameter continuously monitored. * **Stryker Auto-Fuser PainPump:** The bonding process of the glass restrictor to the male luer was not completely validated. Limited test runs were performed, but no documentation of nominal runs or destructive cross-sectional examination of the bond quality was available. This bonding issue was identified as the root cause of an over-infusion malfunction.

* **Failure to Submit MDRs:** Multiple complaints received between January 23, 2009, and February 18, 2009, reporting leakage of fluid or black oil/substance from surgical instruments into the sterile field or patient wound were not reported as Medical Device Reports (MDRs) within 3