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

Model Number	48361234
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that;the tip of two trial handles broke off into the trials in the case.All broken fragments.Replacement device was used to successfully complete the procedure.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the tip of the returned inserter was found fractured.No relevant manufacturing issues were found.Conclusion: it is likely that the device fractured due to patients tight disc space.
Event or Problem Description
It was reported that;the tip of two trial handles broke off into the trials in the case.All broken fragments.Replacement device was used to successfully complete the procedure.

• 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: 6676665
• Report Number: 0009617544-2017-00265
• Device Sequence Number: 16614974
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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 Model Number: 48361234
• Device Catalogue Number: 48361234
• Device Lot Number: 111673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR