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	01/20/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; dr.(b)(6) was inserting a trial when the tip broke off from the trial handle into 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: based on the age of the device it is likely that normal wear contributed to the reported event.
Event or Problem Description
It was reported that; dr.(b)(6) was inserting a trial when the tip broke off from the trial handle into 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: 5442783
• Report Number: 0009617544-2016-00067
• Device Sequence Number: 478356
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147(11)120808(10)127455
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 127455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• 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