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

Catalog Number	48561024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during posterior cervical procedure the screwdrivers stripped out and the persuader broke.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were found upon device history review.Visual inspection did not confirm a deformed tip and the instrument was able to attach to the polyaxial screw without issue.Conclusion: therefore the probable root cause of this event is user related.
Event or Problem Description
It was reported that during posterior cervical procedure the screwdrivers stripped out and the persuader broke.

• 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: 6270637
• Report Number: 0009617544-2017-00033
• Device Sequence Number: 16426303
• Product Code: LXH
• UDI-Device Identifier: 07613327271300
• UDI-Public: (01)07613327271300
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 03/28/2017

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 Catalogue Number: 48561024
• Device Lot Number: 09D909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1