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

Catalog Number	48361234
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was inserting a trial when the trial tip broke in the trial.He used a rongeur to remove the trial.There was no surgical delay.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assesment.Result: the returned device was confirmed to have a fractured tip upon visual inspection.The tip of the handle was found in the returned trial.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The returned device was greater than 8 years old at the time of the event.Conclusion: the probable root cause of this event is normal wear and tear.
Event or Problem Description
It was reported that the surgeon was inserting a trial when the trial tip broke in the trial.He used a rongeur to remove the trial.There was no surgical delay.

• 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: 5726078
• Report Number: 0009617544-2016-00236
• Device Sequence Number: 10901255
• 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): 05/23/2016

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: 08C717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2016
• Supplement Report FDA Received Date: 08/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1