MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR L SCREWDRIVER MODULAR RIGID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48999000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the rigid screw driver tip snapped off during insertion of a screw.
Additional Manufacturer Narrative
Result: the returned was confirmed to have its tip fractured upon visual inspection of the returned device.The fracture pieces were not returned.Both sides of the screwdriver tip were fractured off from the main shaft.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Manufacturing history review revealed that the instrument was manufactured and released more than 3 years ago.The ifu for anchor l indicates that instruments which have experienced extensive use or extensive force are more susceptible to fracture.Conclusion: the plausible root cause of the reported event is normal wear and tear of instruments.
Event or Problem Description
It was reported that; the rigid screw driver tip snapped off during insertion of a screw.

• Brand Name: ANCHOR L SCREWDRIVER MODULAR RIGID
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5858419
• Report Number: 0009617544-2016-00327
• Device Sequence Number: 19196824
• Product Code: LXH
• UDI-Device Identifier: 07613327274905
• UDI-Public: (01)07613327274905
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48999000
• Device Lot Number: 131781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1