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

Model Number	48061000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; while using the shavers in the disc space, the inner tabs on blue t handle broke on both t handles in the reliance lite instruments set.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review; risk assessment; result: the reported event was confirmed via email correspondence with the sales rep and device inspection of the returned product.The inner prongs of the instrument were confirmed to be fractured upon visual inspection.No manufacturing related issues were found upon product history review.Conclusion: based on the information provided, the possible root cause of the reported event is due to normal wear and tear and improper handling (lack of lubrication).
Event or Problem Description
It was reported that; while using the shavers in the disc space, the inner tabs on blue t handle broke on both t handles in the reliance lite instruments set.

• 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: 7052221
• Report Number: 0009617544-2017-00420
• Device Sequence Number: 11095833
• Product Code: LXH
• UDI-Device Identifier: 07613327263671
• UDI-Public: (01)07613327263671
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/07/2018

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: 48061000
• Device Catalogue Number: 48061000
• Device Lot Number: 096836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1