MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS CROSS NUT TIGHTHENER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48561075
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; instrument broke.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The oasys nut tightener has fractured castle tooth.No relevant manufacturing issues were identified as all units met stryker specifications.The plausible root cause of the event was determined to be multifactorial in nature.Factors that may contributed to fracture: instrument/implant jams & user continues to apply force and/or intentional misuse.
Event or Problem Description
It was reported that; instrument broke.

• Brand Name: OASYS CROSS NUT TIGHTHENER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6681580
• Report Number: 0009617544-2017-00271
• Device Sequence Number: 16189878
• Product Code: LXH
• UDI-Device Identifier: 07613327271577
• UDI-Public: (01)07613327271577
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/29/2017

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 Model Number: 48561075
• Device Catalogue Number: 48561075
• Device Lot Number: 161151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1