MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL ADAPTER TIBIA T2 ALPHA TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-4103
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "right tibia t2 orif.After assembling the nail adapter tibia and the targeting arm tibia, the screw was inserted.After that, i tried to remove it, but it could not be removed." delay of 4-5 minutes."at the time of the event, the proximal screw had been inserted, so it was removed from the nail and the distal screw was inserted (radiolucent drill).".
Additional Manufacturer Narrative
The evaluation revealed the targeting arm tibia t2 alpha tibia and the nail adapter tibia t2 alpha tibia to be the primary products; the nail holding screw was not provided.No deviations were found during review of the manufacturing and inspection documents (dhr).Both products returned were documented as faultless prior to distribution.The risk management file review showed that the complained event was addressed adequately; no threshold exceedances found.The event description includes: ¿.After assembling the nail adapter tibia and the targeting arm tibia, the screw was inserted.After that, i tried to remove it, but it could not be removed¿ at the time of the event, the proximal screw had been inserted, so it was removed from the nail and the distal screw was inserted (radiolucent drill).¿ most likely with ¿screw¿ the nail holding screw was meant.The inspection revealed that a sample nail holding screw could be assembled and disassembled easily and within specification, so the reported event was not reproducible.The nail holding screw contains a self-holding clamp that creates a slight resistance.Most likely this resistance caused the event as the user was not familiar with this design feature.If the nail holding screw, used in the surgery, was damaged, this could not be verified.The event was classified as user related (lack of knowledge).
Event or Problem Description
As reported: "right tibia t2 orif.After assembling the nail adapter tibia and the targeting arm tibia, the screw was inserted.After that, i tried to remove it, but it could not be removed." delay of 4-5 minutes."at the time of the event, the proximal screw had been inserted, so it was removed from the nail and the distal screw was inserted (radiolucent drill).".

• Brand Name: NAIL ADAPTER TIBIA T2 ALPHA TIBIA
• Common Device Name: 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: 10632002
• Report Number: 0009610622-2020-00558
• Device Sequence Number: 3248447
• Product Code: HSB
• UDI-Device Identifier: 07613327357059
• UDI-Public: 07613327357059
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193308
• 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): 12/23/2020

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 Model Number: 2353-4103
• Device Catalogue Number: 23534103
• Device Lot Number: KME914287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1