MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS PLUS FLEXIBLE SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48561051
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a single-use instrument exists in (b)(6) kits as a reusable item.
Additional Manufacturer Narrative
Manufacturing records were reviewed and no anomalies were found.There was no non-conformity found with the flexible shaft.
Event or Problem Description
It was reported that a single-use instrument exists in (b)(4) kits as a reusable item.

• Brand Name: OASYS PLUS FLEXIBLE SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5721519
• Report Number: 0009617544-2016-00232
• Device Sequence Number: 489851
• Product Code: LXH
• UDI-Device Identifier: 07613327271492
• UDI-Public: (01)07613327271492
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/17/2016

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: 48561051
• Device Lot Number: 12C690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1