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	01/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the quick release handles broke during surgery.All the broken fragments were retrieved.No adverse health consequences were reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, risk assessment; result: the reported event was confirmed via correspondence with the sales representative 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.According to correspondence with the sales representative, the instrument has been used hundreds of times.Based on the information provided and the age of the device (8 years), the possible root cause of the reported event is due to normal wear and tear.
Event or Problem Description
It was reported that the quick release handles broke during surgery.All the broken fragments were retrieved.No adverse health consequences were reported.

• 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: 7224298
• Report Number: 0009617544-2018-00023
• Device Sequence Number: 16437793
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 108615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1