MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE T HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48061000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was using t-handle with trial attachment in disc space, he then began to remove the trial when he felt something "give way" or break.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; material analysis; device history review; complaint history review; risk assessment.Results: the returned device was confirmed visually to have fractured.Manufacturing records were reviewed and no relevant issues were found and revealed an instrument of approximately 4 years old.Conclusion: the plausible root cause of the reported event is normal material wear based on the age and usage of the device.
Event or Problem Description
It was reported that the surgeon was using t-handle with trial attachment in disc space, he then began to remove the trial when he felt something "give way" or break.

• Brand Name: RELIANCE T 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: 5679819
• Report Number: 0009617544-2016-00207
• Device Sequence Number: 16187959
• Product Code: LXH
• UDI-Device Identifier: 07613327263671
• UDI-Public: (01)07613327263671
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/05/2016

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: 48061000
• Device Lot Number: 122844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1