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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 Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report. Device disposition is unknown.
 
Event Description
It was reported that distal screws missdrilling occurred. Replacement was available. Surgical delay of 8min. Not longer.
 
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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
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9367606
MDR Text Key191808626
Report Number0009610622-2019-00938
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2019
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 NumberKME910241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2017
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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