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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL ADAPTER T2 ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER TRAUMA KIEL NAIL ADAPTER T2 ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 1806-3211
Medical Device Problem Code Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/17/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
 
Event or Problem Description
It was reported that during a primary t2 ankle arthrodesis nail procedure, the lateral calcaneus hole of the targeter did not align with the implant.The procedure was completed by inserting the screw without the use of the targeter.Surgery was completed successfully with no delay.Rep was not present for the procedure, and confirmed that no further information is available.
 
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Brand Name
NAIL ADAPTER T2 ANKLE
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key9705750
Report Number0009610622-2020-00051
Device Sequence Number3654511
Product Code LXH
UDI-Device Identifier04546540708489
UDI-Public04546540708489
Combination Product (Y/N)N
Initial Reporter StateNY
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
Report Date (Section B) 02/13/2020
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 Health Professional
Device Model Number1806-3211
Device Catalogue Number18063211
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/17/2020
Initial Report FDA Received Date02/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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