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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X345 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X345 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18220934S
Device Problem Bent (1059)
Patient Problem No Information (3190)
Event Date 07/25/2016
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The pharmacist at the hospital, reported the following event : "implantation of a t2 tibial nail on (b)(6) 2016.The nail "bent" post operatively, during x-ray control, without trauma.Removal of the nail on (b)(6) 2016 and implantation on another t2 nail.New surgery required in order to change the nail with aseptic risk and risk of fracture of the osteosynthesis implant in case of non removal.
 
Manufacturer Narrative
Referring to the product inquiry the tibial nail is the only reported device and thus considered the primary product.Failures in material or manufacturing were not found.Review of the dhr / inspection records for the returned nail revealed no discrepancies; the device was documented faultless prior to distribution.In particular, it has to be noted, that the bend contour was checked 100%; no deviation was found during inspection processes.The original bend contour of the received nail does not correspond to the specification any more.Nevertheless, the relevant diameters of the nail were found to be within specified tolerances.All available information was forwarded to a consulting hcp for review.His comments: ¿such bends are always generated by coarse action.In addition, a highly unstable fracture is required.Without radiographs a more detailed statement is not possible.¿ the damage patterns found indicate that the original bend contour of the received nail was modified by the user.In particular the bulged outwards material and the damaged thread in the connection area in combination with the significant additional nail bend suggest that the nail has been used intra-operatively as a fracture reduction lever, supported by the nail adapter and targeting arm under massive force application.In case of intended use such damage would not have occurred.Based on the above observations the root cause of the reported event is not linked to a deficiency of the device but is rather related to abnormal use of the implant (using the nail as a fracture reduction lever under massive force application).It has to be noted that stryker is not responsible for the consequences of such abnormal use.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.
 
Event Description
The pharmacist at the hospital, reported the following event : "implantation of a t2 tibial nail on (b)(6) 2016.The nail "bent" post operatively, during x-ray control, without trauma.Removal of the nail on (b)(6) 2016 and implantation on another t2 nail.New surgery required in order to change the nail with aseptic risk and risk of fracture of the osteosynthesis implant in case of non removal.
 
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Brand Name
TIBIAL NAIL, STANDARD T2 TIBIA Ø9X345 MM
Type of Device
ROD, 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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5991592
MDR Text Key56094754
Report Number0009610622-2016-00465
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K003018
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 01/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/31/2020
Device Catalogue Number18220934S
Device Lot NumberKK03504B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2016
Initial Date FDA Received09/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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