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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 TARGET DEVICE; INSTRUMENT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 TARGET DEVICE; INSTRUMENT Back to Search Results
Catalog Number UNK_KIE
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2019
Event Type  malfunction  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event Description
In the positioning of the distal screws of the gamma 200 nail the distal fixing screws have gone beyond the nail.
 
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Brand Name
UNKNOWN GAMMA3 TARGET DEVICE
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8805230
MDR Text Key151711830
Report Number0009610622-2019-00549
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/18/2019
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
Device Operator Health Professional
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/26/2019
Initial Date FDA Received07/18/2019
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
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