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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1320-0111
Device Problem Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported, "long g3 opr. Unable to loosen nail holding screw from nail after implanting nail. Took out rivets, unpacked other instrumentation and rivets and continued opr. " "the operation was almost finished, but when they had to release the nail from the sight arm, this did not work. Took everything out and used a new gamma instrument and a new nail. It went well. Operating time was extended. " "surgeon had implanted the long nail and was supposed to release the nail holding bolt and remove the target device, nail holding screw was locked into the nail. He had to remove nail/target device in one piece and open a new instrument set/nail and continue surgery. They tried to release the nail holding bolt after removed implant from patient, but it was impossible without destroying their screwdriver handle. " a new nail had to be implanted.
 
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Brand NameTARGET DEVICE GAMMA3
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10707647
MDR Text Key212572851
Report Number0009610622-2020-00569
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K123401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1320-0111
Device Catalogue Number13200111
Device Lot NumberKME909563-244747
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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