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

Model Number	48328550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; broken screwdriver during implantation.No patient injury.Surgery was completed as planned.
Additional Manufacturer Narrative
Risk assessment; res the instrument was not returned for evaluation as it was disposed at the hospital.Device history review and complaint history review was not performed as the lot # was not provided and device was not returned.A plausible root cause could not be identified conclusively because the instrument was not returned for evaluation.
Event or Problem Description
It was reported that; broken screwdriver during implantation.No patient injury.Surgery was completed as planned.

• 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: 6638473
• Report Number: 0009617544-2017-00242
• Device Sequence Number: 892429
• Product Code: LXH
• UDI-Device Identifier: 07613327126273
• UDI-Public: (01)07613327126273
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/24/2017

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 Model Number: 48328550
• Device Catalogue Number: 48328550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1