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

Catalog Number	IS3107OAS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the device cracked and almost sheared off of the screwdriver.
Additional Manufacturer Narrative
Method: visual inspection; material analysis; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to have a worn hex tip.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 manufacturing issues were found for this lot number and it was revealed to have been in the field for approximately 1 year.Conclusion: damages were observed on the tip at the crack origin so the probable root cause is normal wear.
Event or Problem Description
It was reported that the tip of the device cracked and almost sheared off of the screwdriver.

• 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: 5439415
• Report Number: 3004024955-2016-00016
• Device Sequence Number: 16218785
• Product Code: LXH
• UDI-Device Identifier: 07613327142181
• UDI-Public: 07613327142181
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/21/2016

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: 02/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2016
• Supplement Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1