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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Malposition of Device (2616)
Patient Problems Perforation (2001); Hip Fracture (2349)
Event Date 03/25/2021
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
"the stryker sales representative reported that a patient who had been implanted with a gamma nail and a lag screw was revised. It was noticed post operatively that the nail was fine, but the lag screw had perforated the femoral head and migrated towards the pelvis. The healing process had finished when the lag screw went into the bone. There was no damage to arteries. The stryker sales representative noticed bony in growth between the explanted lag and set screws. The sales representative tried to remove the set screw from the explanted nail after the case but it had threaded onto the nail and was stuck".
 
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Brand NameUNKNOWN GAMMA NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11680452
MDR Text Key245848142
Report Number0009610622-2021-00443
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/16/2021 Patient Sequence Number: 1
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