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

Catalog Number	48061000
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when releasing handle from trial shaft a small shaving of metal fell out of the quick release mechanism.
Additional Manufacturer Narrative
Catalog# 48061000.Lot# 096836.Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The complaint device has been manufactured for around 8 years and used hundreds of times in the possession of the reporter.Conclusion: the most likely cause of the reported event was determined to be the overload during long-term usage.
Event or Problem Description
It was reported that; when releasing handle from trial shaft a small shaving of metal fell out of the quick release mechanism.

• 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: 6340636
• Report Number: 0009617544-2017-00059
• Device Sequence Number: 16376937
• Product Code: LXH
• UDI-Device Identifier: 07613327272772
• UDI-Public: (01)07613327272772
• 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): 05/10/2017

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: 14C157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1