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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
Model Number 2353-3103
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
The customer reported that the patient on traction table.Surgery to implant a t2 alpha nail was proceeding as normal, checked nail alignment before introducing nail into femoral canal, all normal.Nail down, ap x-ray view satisfactory, wire introduced in sleeve a (inferior), good position on ap.Lateral view, wire anterior, modified the nail position, second attempt wire goes through femoral neck and head.Satisfactory.Go back to ap view and position of the nail now is to high, retrieve wire, retrieve sleeves, nail introduced further down in canal.After this point we were not able to pass the wire through the sleeve.Wire tip broke on lateral cortex.Pre drilling lateral cortex was advised but ignored.Change the procedure to gamma nail.We did check the jig attachment to the nail and it was tight, no loosen observed.Removal of t2 alpha nail in the case and implantation of gamma nail.
 
Event Description
The customer reported that the patient on traction table.Surgery to implant a t2 alpha nail was proceeding as normal, checked nail alignment before introducing nail into femoral canal, all normal.Nail down, ap x-ray view satisfactory, wire introduced in sleeve a (inferior), good position on ap.Lateral view, wire anterior, modified the nail position, second attempt wire goes through femoral neck and head.Satisfactory.Go back to ap view and position of the nail now is to high, retrieve wire, retrieve sleeves, nail introduced further down in canal.After this point we were not able to pass the wire through the sleeve.Wire tip broke on lateral cortex.Pre drilling lateral cortex was advised but ignored.Change the procedure to gamma nail.We did check the jig attachment to the nail and it was tight, no loosen observed.Removal of t2 alpha nail in the case and implantation of gamma nail.
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and thus, limited to details available.According to event description the device in question was tested pre-surgical and also post-surgical.During both, simulation of pre-surgical function check and also after the procedure, the device in question was found to be fully functional, which was confirmed by the customer.Based on above facts the case is rather related to a sub-optimal intraoperative procedure and has to be classified as user related.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
 
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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
GM  D-24232
MDR Report Key12018276
MDR Text Key256777764
Report Number0009610622-2021-00564
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613327338652
UDI-Public07613327338652
Combination Product (y/n)N
PMA/PMN Number
K191271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/22/2021
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 Model Number2353-3103
Device Catalogue Number23533103
Device Lot NumberKP431228
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/25/2021
Initial Date FDA Received06/17/2021
Supplement Dates Manufacturer Received09/09/2021
Supplement Dates FDA Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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