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

Catalog Number	18220934S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that, during a tibial nail procedure, when it came time to attach the nail to the holding bolt, the threads inside the nail would not engage with the holding bolt.Multiple attempts with no success.A second nail was opened and the nail successfully engaged with the holding bolt.Two minute surgical delay reported.No adverse consequences were reported.
Event or Problem Description
It was reported that, during a tibial nail procedure, when it came time to attach the nail to the holding bolt, the threads inside the nail would not engage with the holding bolt.Multiple attempts with no success.A second nail was opened and the nail successfully engaged with the holding bolt.Two minute surgical delay reported.No adverse consequences were reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and visual and functional inspection confirmed the failure mode.Based on investigation, the root cause was attributed to user related issue.The failure was caused by handling error due to application of too much force while screwing it with nail holding screw.The device inspection revealed the following: visual inspection: through the visual examination of the provided t2 tibia nail, scratches, slight abrasion and top two threads damage can be seen around the connection area which clearly states that its connection with the nail holding screw was not smooth which led to application of extra force to make the connection.Functional inspection: upon functional inspection of the two devices, it was found that the connection between the reported nail and the reported nail holding screw was not possible.There was no sign of damage on the nail holding screw.However, threads of the nail were found damaged.Upon further evaluation, when the reported nail holding screw was used with a sample nail, the connection between them was found perfect.This suggests that the nail holding screw was not the immediate cause, but the nail was.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø9X345 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8483110
• Report Number: 0009610622-2019-00143
• Device Sequence Number: 13781786
• Product Code: HSB
• UDI-Device Identifier: 04546540197788
• UDI-Public: 04546540197788
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 18220934S
• Device Lot Number: K0E3001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1