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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 CANNULATED MODULAR TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
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STRYKER SPINE-FRANCE ES2 CANNULATED MODULAR TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. Back to Search Results
Catalog Number 48280145
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event 08/24/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that when the surgeon used the 4.5 mm tap to the right side, its tip broke.The surgeon removed all the fragments and inserted a screw.
 
Event or Problem Description
It was reported that when the surgeon used the 4.5mm tap to th6 right side, its tip broke.The surgeon removed all the framents and inserted a screw.
 
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Brand Name
ES2 CANNULATED MODULAR TAP
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
MDR Report Key6877394
Report Number0009617544-2017-00360
Device Sequence Number891960
Product Code LXH
UDI-Device Identifier04546540710413
UDI-Public(01)04546540710413
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/03/2018
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 Catalogue Number48280145
Device Lot Number14D391
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2017
Initial Date Received by Manufacturer 08/24/2017
Supplement Date Received by Manufacturer08/24/2017
Initial Report FDA Received Date09/19/2017
Supplement Report FDA Received Date01/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age78 YR
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