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

Model Number	48994000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screwdriver tip broke.
Additional Manufacturer Narrative
The customer reported event of screwdriver tip fracture was confirmed via visual inspection.Manufacturing history was reviewed and no issues were identified.The age of the instrument was found to be almost 4 years old.Conclusion: a root cause of the event is most likely normal wear and tear.
Event or Problem Description
It was reported that; screwdriver tip broke.

• Brand Name: ANCHOR L SCREWDRIVER MODULAR 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: 6843619
• Report Number: 0009617544-2017-00348
• Device Sequence Number: 11163025
• Product Code: LXH
• UDI-Device Identifier: 07613327274578
• UDI-Public: (01)07613327274578
• Combination Product (Y/N): N
• 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): 11/30/2017

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 Model Number: 48994000
• Device Catalogue Number: 48994000
• Device Lot Number: 13E681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1