MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS PERSUADER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48561024
Medical Device Problem Codes	Disassembly (1168); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; persuader screw broke.Update 3-jun-2016: we were trying to persuade the rod into the tulip head.
Additional Manufacturer Narrative
Method: visual analysis, complaint history review, device history review, risk assessment.Result: the returned device was inspected and found that the retaining screw on the upper part of the trigger mechanism was missing preventing the top portion of the persuader to slide with the pull of the trigger.Further inspection of the screw hole with a microscope showed deformity to the right side screw hole implying wear and tear issue.No relevant manufacturing issues were found upon device history review.Conclusion: the probable root cause of this event is normal wear and tear of instruments.
Event or Problem Description
It was reported that; persuader screw broke.Update 3-jun-2016: we were trying to persuade the rod into the tulip head.

• Brand Name: OASYS PERSUADER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5749006
• Report Number: 0009617544-2016-00248
• Device Sequence Number: 13457632
• Product Code: LXH
• UDI-Device Identifier: 07613327271300
• UDI-Public: (01)07613327271300
• 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): 06/02/2016

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: 48561024
• Device Lot Number: 12C536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2016
• Supplement Report FDA Received Date: 09/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1