MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SLIDE TRIAL HANDLE; PEDIC 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	10/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial (26x32, 11 8 degrees) broke off of trial inserted with threaded portion of trial inserter stuck in trial.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was inspected and it was found that the tip of the slide handle was fractured.No relevant manufacturing issues were identified for the reported lot.The plausible root cause is "normal wear based on age and extensive use of the device.".
Event or Problem Description
It was reported that the trial (26x32, 11 8 degrees) broke off of trial inserted with threaded portion of trial inserter stuck in trial.

• Brand Name: SLIDE TRIAL HANDLE
• Common Device Name: PEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6118673
• Report Number: 0009617544-2016-00470
• Device Sequence Number: 994288
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

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: 149218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1