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

Catalog Number	48999000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon broke the screwdriver.Surgeon was putting a screw in and the screwdriver broke.Another screwdriver.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.Upon visual inspection of the returned device, half of the screwdriver tip had fractured off.The fractured piece was not returned.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 normal wear and tear.
Event or Problem Description
It was reported that the surgeon broke the screwdriver.Surgeon was putting a screw in and the screwdriver broke.Another screwdriver.

• 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: 6205903
• Report Number: 0009617544-2016-00502
• Device Sequence Number: 13547659
• Product Code: LXH
• UDI-Device Identifier: 07613327274905
• UDI-Public: (01)07613327274905
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2017

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: 48999000
• Device Lot Number: 127682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1