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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 23533103
Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2019
Event Type  malfunction  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event Description
It was reported that, during a primary procedure on a right femur, the strike plates with the t2 greater troch system wouldn't thread onto the targeter.Plates were cross threaded.Surgery completed by impacting the bottom of the targeter, which in turn became damaged.Surgical delay of approximately 45 minutes.
 
Event Description
It was reported that, during a primary procedure on a right femur, the strike plates with the t2 greater troch system wouldn't thread onto the targeter.Plates were cross threaded.Surgery completed by impacting the bottom of the targeter, which in turn became damaged.Surgical delay of approximately 45 minutes.
 
Manufacturer Narrative
The reported event of instrument destruction was confirmed.Review of the dhr revealed the item had been manufactured to specs.Review of rmf, capa and complaint history revealed no abnormalities.With above evidences it was concluded the target device had been damaged in such a way that the internal thread, potentially already damaged in a former surgery, was destroyed by impacting an insufficiently attached strike plate.Consequently, surgery was completed by impacting the underside of the targeting arm and impacting the bottom of the targeter, which in turn became damaged.For intended effect a tight fit with the thread of the counterpart is required.Functional check prior to use is required in the labelling ¿ such as ifu.The cause of the damage was regarded as user related.A deficiency of the device was not verified.
 
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Brand Name
TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
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 Key8474781
MDR Text Key140955362
Report Number0009610622-2019-00132
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613327338652
UDI-Public07613327338652
Combination Product (y/n)N
PMA/PMN Number
K172774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number23533103
Device Lot NumberKP423047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2019
Date Manufacturer Received05/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age13 YR
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