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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; attempted to insert the cage in c6/7 using the flexible driver , the driver was broken due to excessive angle during insertion.Other straight driver was used and complete the procedure.
Additional Manufacturer Narrative
Lot #: 146869.The customer reported event was confirmed via visual inspection.The flexible shaft of the device is fractured.Manufacturing history was reviewed and no issues were identified.A root cause of the event is user error specifically bending the flexible screwdriver to the excessive angle/ bending past the limitations listed in a surgical technique.
Event or Problem Description
It was reported that; attempted to insert the cage in c6/7 using the flexible driver, the driver was broken due to excessive angle during insertion.Other straight driver was used and complete the procedure.

• 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: 6843614
• Report Number: 0009617544-2017-00347
• Device Sequence Number: 13853165
• Product Code: LXH
• UDI-Device Identifier: 07613327126273
• UDI-Public: (01)07613327126273
• Combination Product (Y/N): N
• 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): 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: 48328550
• Device Catalogue Number: 48328550
• Device Lot Number: 146869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• 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