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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE T HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER SPINE-FRANCE RELIANCE T HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 48061000
Medical Device Problem Codes Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/30/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that; doctor was turning a shaver in a disc space when a handle broke.
 
Additional Manufacturer Narrative
Manufacturing records were reviewed for the corresponding lot, and no relevant manufacturing issues were identified.The handle was inspected and it was found that half of the inner locking collar was fractured and missing from the device.The device is 6 years old.The most plausible root cause of the event was determined to be normal wear due to multiple use.
 
Event or Problem Description
It was reported that; doctor was turning a shaver in a disc space when a handle broke.
 
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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 Key6746566
Report Number0009617544-2017-00292
Device Sequence Number137278
Product Code LXH
UDI-Device Identifier07613327263671
UDI-Public(01)07613327263671
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
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) 12/27/2017
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 Model Number48061000
Device Catalogue Number48061000
Device Lot Number114235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2017
Initial Date Received by Manufacturer 06/30/2017
Supplement Date Received by Manufacturer06/30/2017
Initial Report FDA Received Date07/27/2017
Supplement Report FDA Received Date12/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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