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	03/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two t handles broke.Doctor was trying to distract very tight disc space and the two t handles broke.Used another t handle from a backup tray.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was confirmed by the returned product to have fractured.Manufacturing records were reviewed and no relevant issues were found and revealed an instrument of approximately 2 years old.Conclusion: the possible root causes of the reported event could be: mishandling of the instrument, instrument cannot handle force applied to insert disc in space and user applies rotational/cantilever force.
Event or Problem Description
It was reported that two t handles broke.Doctor was trying to distract very tight disc space and the two t handles broke.Used another t handle from a backup tray.

• 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: 5607704
• Report Number: 0009617544-2016-00163
• Device Sequence Number: 16150103
• Product Code: LXH
• UDI-Device Identifier: 07613327263671
• UDI-Public: (01)07613327263671
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/30/2016

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: 143829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2016
• Supplement Report FDA Received Date: 06/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR