MAUDE Adverse Event Report: STRYKER SPINE-US SPECIALTY OASYS SCREWDRIVER WITH LOCK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS3107OAS
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	03/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screwdriver tip cracked and broke.
Additional Manufacturer Narrative
Results: no manufacturing issues were found for this lot number.Visual inspection indicated; the returned part was examined and the tip was observed to be cracked.Materials analysis was performed and found that the cracks on the submitted screwdrivers both appeared to originate from damage on the tips at the corner of the hex.No material or manufacturing defects were found.Conclusion: the probable root cause is normal wear.
Event or Problem Description
It was reported that: screwdriver tip cracked and broke.

• Brand Name: SPECIALTY OASYS SCREWDRIVER WITH LOCK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5531655
• Report Number: 3004024955-2016-00035
• Device Sequence Number: 18898562
• Product Code: LXH
• UDI-Device Identifier: 07613327142181
• UDI-Public: (01)07613327142181
• 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): 03/07/2016

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 Catalogue Number: IS3107OAS
• Device Lot Number: 23019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2016
• Supplement Report FDA Received Date: 05/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR