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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3125-1200S
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)
Event Date 04/01/2022
Event Type  Injury  
Event Description
It was reported that "a gamma nail broke this 01/04 during an intervention at the ch of chateauroux. " additional information received: the nail broke post-operatively, likely non-union was observed. A revision to total hip prosthesis was performed.
 
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14208292
MDR Text Key290073412
Report Number0009610622-2022-00152
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3125-1200S
Device Catalogue Number31251200S
Device Lot NumberK073525
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? No
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: 04/26/2022 Patient Sequence Number: 1
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