MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48770905B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; draw rod tip broke when screw was being inserted.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The screwdriver was confirmed to have a tip fracture.Manufacturing files were reviewed and no issues were found.The fragment was retrieved but not returned.The likely root cause is due to normal wear.
Event or Problem Description
It was reported that; draw rod tip broke when screw was being inserted.

• Brand Name: AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6553723
• Report Number: 0009617544-2017-00185
• Device Sequence Number: 905551
• Product Code: LXH
• UDI-Device Identifier: 07613327276886
• UDI-Public: (01)07613327276886
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/25/2017

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: 48770905B
• Device Catalogue Number: 48770905B
• Device Lot Number: 091699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1