MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA 11X330 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1822-1133S

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "t2 tibia nail unable to be disconnected from nail adapter.".

Manufacturer Narrative

The reported event could be confirmed, although the device was not returned for evaluation, but a few images were shared which confirms the alleged failure.A device inspection was not possible since the affected device was not returned.However, a few images from the complaint site were received through which the alleged failure could be confirmed.The nail, nail adapter and the nail holding screw appeared to be stuck.The nail adapter was observed to be not properly engaged with the nail, while the nail holding screw was also partially inserted, most likely due to the jamming.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.More information as well as the device must be available in order to determine the exact root cause.However, the most probable cause of the failure is the seizing of nail holding screw with the nail under high loading with some misalignment of the threads involved (cold welding).If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.

Event Description

As reported: "t2 tibia nail unable to be disconnected from nail adapter.".

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA 11X330 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; GM D-24232
• MDR Report Key: 11098175
• MDR Text Key: 227757714
• Report Number: 0009610622-2020-01087
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540198037
• UDI-Public: 04546540198037
• Combination Product (y/n): N
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 1822-1133S
• Device Catalogue Number: 18221133S
• Device Lot Number: K0E6A5C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR