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

Model Number	48328550
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during an acdf case the surgeon over flexed the flexible screwdriver and it snapped.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the returned device was confirmed to have broken shaft in the flexible region.No relevant issues were identified in the manufacturing records.Conclusion: the plausible root cause of the reported event is bending the flexible screwdriver to the excessive angle/bending past the limitations listed in surgical technique to accommodate for patient¿s difficult anatomy.
Event or Problem Description
It was reported that; during an acdf case the surgeon over flexed the flexible screwdriver and it snapped.

• 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: 6908893
• Report Number: 0009617544-2017-00371
• Device Sequence Number: 19160804
• Product Code: LXH
• UDI-Device Identifier: 07613327126273
• UDI-Public: (01)07613327126273
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 12/18/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1