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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
Catalog Number 13200111
Device Problems Loose or Intermittent Connection (1371); Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Date 01/02/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Primary procedure, left femur.It was reported that the threaded area of the gamma targeter for the extraction bolt would not hold the bolt due to the threads being deformed.The nail was explanted and a new nail implanted because the surgeon had reamed for a smaller nail and did not go distally enough.To remove the nail, the surgeon had to hit the targeter with a mallet after wrapping it in towels.A surgical delay of approximately 2 minutes was reported.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
 
Manufacturer Narrative
The reported event that target device gamma3® was alleged of issue (assembling / disassembling of instruments with instruments) could not be confirmed, since the device was returned for evaluation and was found to be fully functional.The device inspection revealed the following: the returned product showed signs of extensive usage.Few scratches and dent marks were observed on the surface of the targeting device.No further visible damages were found.Functional inspection: the returned device was assembled with sample instruments.The pre- operational test was performed with proximal drill position and distal static oblong drill position and the reported failure was not reproducible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.Based on the investigation the root cause of the reported event is not related to the deficiency of the device but rather related to user issue due to sub optimal intra operative technique.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
 
Event Description
Primary procedure, left femur.It was reported that the threaded area of the gamma targeter for the extraction bolt would not hold the bolt due to the threads being deformed.The nail was explanted and a new nail implanted because the surgeon had reamed for a smaller nail and did not go distally enough.To remove the nail, the surgeon had to hit the targeter with a mallet after wrapping it in towels.A surgical delay of approximately 2 minutes was reported.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
 
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Brand Name
TARGET DEVICE GAMMA3®
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8283534
MDR Text Key135738485
Report Number0009610622-2019-00059
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540716774
UDI-Public04546540716774
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
Type of Report Initial,Followup
Report Date 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number13200111
Device Lot NumberKME904394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2019
Initial Date Manufacturer Received 01/02/2019
Initial Date FDA Received01/28/2019
Supplement Dates Manufacturer Received03/07/2019
Supplement Dates FDA Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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