MAUDE Adverse Event Report: STRYKER GMBH END CAP, STANDARD T2 Ø8 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18220003S
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "when attempting to place the standard plug of the t2 tibia nail through the frame, the specialist reports that it does not fit.After removing the frame, the plug still does not screw in.Another implant is then used, and this one fits correctly".
Additional Manufacturer Narrative
Correction - please refer to d9 - the product was returned for evaluation, h6 method code.The reported event could not be confirmed since the returned device was found fully functional.The device inspection revealed the following: in the received end cap screw, minor deformation observed in the threads it looks like multiple attempts were made to insert the screw forcefully.The crest of the screw threads is found slightly flattened which indicates that the screw was not properly aligned with the mating threads at the time of insertion and after application of excess force has flattened the crest of the screw threads during the progression of the screw in mating part.Also, the tightening marks are seen even on the topmost thread of the screw which shows that the screw was tightened till that point but due to improper alignment in the mating part, it might have not seated properly.A functional inspection was done on the returned end cap screw using a sample nail in which we were able to assemble the screw inside the nail properly which shows that the screw is functional even after carrying minor deformations from usage during alleged failure.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 material or manufacturing related problems were found during the investigation.Based on the investigation, the root cause was attributed to be a user related issue as the device is found fully functional and could be assembled as per instructions indicated in the operative technique.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "when attempting to place the standard plug of the t2 tibia nail through the frame, the specialist reports that it does not fit.After removing the frame, the plug still does not screw in.Another implant is then used, and this one fits correctly".

• Brand Name: END CAP, STANDARD T2 Ø8 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20646275
• Report Number: 0009610622-2024-00907
• Device Sequence Number: 20709422
• Product Code: HSB
• UDI-Device Identifier: 04546540197542
• UDI-Public: (01)04546540197542(11)240209(17)290131(10)K1A32E3
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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 Catalogue Number: 18220003S
• Device Lot Number: K1A32E3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 70 KG