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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3125-1180S
Device Problem Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Customer reports a gamma3 targeting device that can't be detached from the gamma3 nail. The nail was properly connected to the targeting device for implantation of a gamma nail (180 length). At the end of the surgery, the retaining screw could not be loosened. As a result, it was necessary to remove the entire gamma nail and re-implant a new gamma nail with a replacement instrument set.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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
MDR Report Key12166756
MDR Text Key261488635
Report Number0009610622-2021-00595
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3125-1180S
Device Catalogue Number31251180S
Device Lot NumberK094CB2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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