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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 07/21/2021
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device discarded by the hospital.
 
Event Description
Please see user report to (b)(6) translated below: fracture of the gamma 3 nail (statically locked). The osteosynthesis material broke in the passage of the sh screw (femoral neck thus variably dislocated). The gamma 3 nail was disposed of after consultation with the patient. On (b)(6) 2021: pertrochanteric femur fracture with osteosynthetic treatment (gamma 3 nail). On (b)(6) 2021 fall and patient admission in the clinic (cct - exclusion of trauma sequelae). On (b)(6) 2021: admission in the clinic (without trauma) - acute pain symptoms and referral to endogap on (b)(6) 2021. On (b)(6) 2021 removal of the broken gamma 3 nail (statically locked) and supply with a cementless htep (cerclage femur).
 
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Brand NameUNKNOWN GAMMA 3 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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12392233
MDR Text Key268975641
Report Number0009610622-2021-00674
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
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: 08/31/2021 Patient Sequence Number: 1
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