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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1320-0111
Device Problem Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device is not available; hospital retained.
 
Event Description
As reported: "during the calibration of the distal aiming device in a gamma3 operation, it was found intraoperatively that the tolerance deviates in the longitudinal axis, but that this cannot be set via the aiming device. The deviation was estimated to be 1mm so that the drill could not pass. Stryker employee checked all aiming bars in the clinic immediately after the event was announced. It was found that the deviation can always be enforced in different combinations, since the tolerance of the pin in the adjusting device in particular allows a slight rotation. In extreme cases, this leads to the deviation described above. The distal locking had to be done manually according to the standard method. Surgical delay of 10 minutes not longer. No other consequences reported. ".
 
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Brand NameDISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5
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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10766622
MDR Text Key214171721
Report Number0009610622-2020-00623
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K123401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1320-0111
Device Catalogue Number13205316
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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