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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø12X420 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø12X420 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18251242S
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The pharmacist assistant at the hospital, reported that it was not possible to lock up the implant. When placing the implant, proximal locking was not possible. There was an increase in surgical time approximately by one hour and a half to two hours.
 
Manufacturer Narrative
The product inquiry had listed the nail as the primary product. The instruments, because allegedly fully functional, were considered to be concomitant items. Review of the dhr / inspection records for the device in question revealed no discrepancies. The device was documented as faultless prior to distribution. A (pre-operational) functional check revealed no deficiency of the nail¿s drill holes. All drill holes were passed without nail contact. The labelling include that every unit, interaction between implant and instrument(s), must be checked prior to every surgery ¿ paying attention to a firmly tightened nail holding screw. The operative technique describes in detail the functional check. Upon functional check of the returned nail it turned out that an, accidentally and not realized, cross threaded fixation screw may have led to the reported. It was possible to reproduce the found drill marks exactly in slight torsional displacement (a poorly tightened nail holding screw may have caused damages in more axial (proximal or distal) direction. In order to ease fixation of handle and target device a so called fixation screw clamp (catalogue #18060273) has been developed to further improve the product handling; oblique insertion of the fixation screw into the corresponding internal thread of the targeting arm will be avoided, as after clamping this device onto the metal part of the targeting arm a straight insertion is ensured. This fixation screw clamp is available since 2010. Based on the above facts and considering that confirmed pre-operative check had been performed it was concluded that the case was attributed to a suboptimal intraoperative procedure. Surgical delay was most double checking the targeting accuracy intra-operatively and by providing new equipment to finalize the surgery. Review of complaint history, capa databases and risk analysis did not identify any conspicuity. The review of the risk assessment for the failure mode indicated the issue was addressed adequately. There are no actions in place related to the reported event for the subject product. No non-conformity was identified. With available information no deficiency of the nail was verified.
 
Event Description
The pharmacist assistant at the hospital, reported that it was not possible to lock up the implant. When placing the implant, proximal locking was not possible. There was an increase in surgical time approximately by one hour and a half to two hours.
 
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Brand NameFEMORAL NAIL, A/R T2 FEMUR Ø12X420 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6376707
MDR Text Key69330659
Report Number0009610622-2017-00068
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K010801
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 05/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Catalogue Number18251242S
Device Lot NumberK0B2EC5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/03/2017 Patient Sequence Number: 1
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