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

Model Number	48361234
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	06/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an l4-5 surgery, the tip of the trial handle broke off.The procedure was completed successfully and no adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Method: labeling review, risk assessment.Results: the reported event was confirmed via communication with the representative.The device was not returned and no lot number was provided, therefore no further inspection or review could be performed.Per email correspondence with the representative, the procedure was done successfully.Disc space was prepared normally and the angle was good.Surgeon had no difficulty.It appeared that the patient had normal bone quality.The representative is not sure how many times the items were used.The ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.Conclusion: it is possible that the device fractured due to extensive use, however it could not be determined conclusively.
Event or Problem Description
It was reported that during an l4-5 surgery, the tip of the trial handle broke off.The procedure was completed successfully and no adverse consequences to the patient were reported.

• Brand Name: SLIDE TRIAL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7656594
• Report Number: 0009617544-2018-00164
• Device Sequence Number: 2012141
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147
• Combination Product (Y/N): N
• 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): 09/27/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1