MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C SCREWDRIVER - FLEXIBLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that using the flexible screwdriver in a case, doctor exceeded the angle limits and broke the shaft.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The event was confirmed based on visual inspection if the returned device.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The plausible root cause of the reported event is user error/misuse specifically bending the flexible screwdriver past the limitations listed in surgical technique.
Event or Problem Description
It was reported that using the flexible screwdriver in a case, doctor exceeded the angle limits and broke the shaft.

• Brand Name: ANCHOR C SCREWDRIVER - FLEXIBLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6138232
• Report Number: 0009617544-2016-00479
• Device Sequence Number: 16270765
• Product Code: LXH
• UDI-Device Identifier: 07613327126273
• UDI-Public: (01)07613327126273
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/27/2017

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: 48328550
• Device Lot Number: 111875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1