MAUDE Adverse Event Report: STRYKER SPINE-US 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	02/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the inner shaft of the handle broke while distracting the disc space.The surgery was successfully completed.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the reported event was not confirmed.The device was found fully functional upon device evaluation.No visual anomalies were found.Instrument instructions for use state that "for instruments with articulations, lubrication may be necessary.Using a silicone lubricating cream is recommended." per email correspondence with the sales rep, the instrument is not lubricated regularly and was not lubricated prior to the surgery.Conclusion: device was found fully functional upon device evaluation.Therefore, the exact root cause of the reported event could not be determined however not lubricating the instrument regularly may have contribute to the reported event.
Event or Problem Description
It was reported the inner shaft of the handle broke while distracting the disc space.The surgery was successfully completed.There are no reports of adverse health consequences to the patient.

• Brand Name: RELIANCE T HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7358009
• Report Number: 0009617544-2018-00072
• Device Sequence Number: 1950240
• Product Code: LXH
• UDI-Device Identifier: 07613327263671
• UDI-Public: (01)07613327263671
• Combination Product (Y/N): N
• 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): 05/25/2018

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: 173187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1