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

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.

• 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 Key: 5991592
• MDR Text Key: 56094754
• Report Number: 0009610622-2016-00465
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• 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 Date: 10/31/2020
• Device Catalogue Number: 18220934S
• Device Lot Number: KK03504B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention