MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SLIDE TRIAL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48361234
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; trial threads broke off in trial.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The device was inspected and it was found that the tip of the slide handle was fractured.The fractured piece was stuck in the returned trial.Manufacturing history was reviewed and no issues were identified.Age of the instrument was found to be more than 3 years old.Conclusion: a root cause of the event is normal wear and tear and extensive use of the instrument.The stryker instrument ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.
Event or Problem Description
It was reported that; trial threads broke off in trial.

• Brand Name: SLIDE TRIAL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7150786
• Report Number: 0009617544-2017-00444
• Device Sequence Number: 10781350
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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: 48361234
• Device Catalogue Number: 48361234
• Device Lot Number: 149218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR