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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM TORQUE WRENCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER SPINE-FRANCE XIA 3 TITANIUM TORQUE WRENCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 48237028
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event 10/31/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that; torque wrench broke when being used to final tighten spine construct.Counter torque standard instrument was used as well.Update 11/7/2017: tip of instrument broke.All broken fragments were retrieved.
 
Event or Problem Description
It was reported that; torque wrench broke when being used to final tighten spine construct.Counter torque standard instrument was used as well.Update 11/7/2017: tip of instrument broke.All broken fragments were retrieved.
 
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Brand Name
XIA 3 TITANIUM TORQUE WRENCH
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
MDR Report Key7049811
Report Number0009617544-2017-00414
Device Sequence Number1423443
Product Code LXH
UDI-Device Identifier07613327265514
UDI-Public(01)07613327265514
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) 02/23/2018
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 Number48237028
Device Catalogue Number48237028
Device Lot Number093656
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2017
Initial Date Received by Manufacturer 10/31/2017
Supplement Date Received by Manufacturer01/29/2018
Initial Report FDA Received Date11/21/2017
Supplement Report FDA Received Date02/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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