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

Catalog Number	48361234
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon hammering an a trial into the disc space, the inserter threaded tip broke and left the trial disengaged in the disc space rep found the tip of the inserter in the trial.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to have a fractured tip upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the plausible root cause of the reported event is likely normal wear from extensive use and a cantilever overload applied by the user.
Event or Problem Description
It was reported that upon hammering an a trial into the disc space, the inserter threaded tip broke and left the trial disengaged in the disc space rep found the tip of the inserter in the 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: 5442782
• Report Number: 0009617544-2016-00066
• Device Sequence Number: 18931622
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147(10)138063(11)130708
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/22/2016

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: 48361234
• Device Lot Number: 138063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2016
• Supplement Report FDA Received Date: 03/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR