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	11/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that due to severe sacral tilt, surgeon struggled trialing at l5-s1.Two trial tips were broken and one tip remained inside the trial itself.
Additional Manufacturer Narrative
Visual inspection, deice history review, complaint history review, risk assessment.The tip of the returned trial handles were fractured.No relevant manufacturing issues found upon manufacturing history review.The plausible root causes for the reported event are normal wear and tear and user error.
Event or Problem Description
It was reported that due to severe sacral tilt, surgeon struggled trialing at l5-s1.Two trial tips were broken and one tip remained inside the trial itself.

• 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: 6138221
• Report Number: 0009617544-2016-00477
• Device Sequence Number: 10986216
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017

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 Catalogue Number: 48361234
• Device Lot Number: 14H648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR