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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN TARGET DEVICE; INSTRUMENT
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STRYKER TRAUMA KIEL UNKNOWN TARGET DEVICE; INSTRUMENT Back to Search Results
Catalog Number UNK_KIE
Device Problem Failure to Align (2522)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/07/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
 
Event Description
It was reported, when the lag screw was inserted, it interfered with the screw hole of the nail and the screw tip was damaged.The broken tip was left inside the patient.The patient was young and his bone quality was good, so the direction was slightly deviated and could not be corrected.
 
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Brand Name
UNKNOWN TARGET DEVICE
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE   D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9659614
MDR Text Key191472874
Report Number0009610622-2020-00038
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeJP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age18
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