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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 13200100
Device Problem Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/04/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
The customer reported: "on (b)(6) 2021, a reduction and osteosynthesis were performed with a gamma nail. At the beginning of the operation, the barrel and aiming tests didn't detect any problem. The aiming frame was visually intact. During distal locking, a shift in the aiming frame resulted in the screw being screwed into the nail instead of the intended screw hole. Locking had to be performed without a sighting frame with a 35mm round hole screw. Particles were visualized on the operated area and had to be removed increased intervention time of more than 30 minutes. No clinical consequences observed to date. ".
 
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Brand NameTARGET DEVICE GAMMA3® 300X160MM
Type of DeviceORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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 Key12634837
MDR Text Key277099896
Report Number0009610622-2021-00760
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13200100
Device Lot NumberKME902820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2010
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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