MAUDE Adverse Event Report: STRYKER GMBH HOFFMANN LRF TELESCOPIC STRUT SHORT LENGTH: 119-161MM (YELLOW); APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49330120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the strut was broken.
Event or Problem Description
It was reported that the strut was broken.Additional information: it was during the adjustment, the surgeon said that he had a lot of tension on the strut.He turned it and then it snapped.A new strut was used.
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that the instrument is indeed broken as reported.It is broken right at one of the hinge sections of the part.Quality assurance engineering reviewed the received information and noted: we have analyzed the complained part and have come to the following conclusion.According to the information provided in the event description, the strut fractured during adjustment while under significant tension.Based on our technical evaluation, we understand that the adjustment involved repositioning the internal joint of the strut.For proper realignment, the fixing screw must first be loosened.Inspection of the screw head shows clear signs of deformation, indicating that it was tightened under excessive force.Furthermore, the joint was in an angled position at the time of adjustment.It appears that considerable force was applied in an attempt to move or loosen the joint while the screw was still tightened.As a result, the component was subjected to high torsional and shear stresses.The fracture occurred at the point of maximum stress concentration, which is consistent with overload conditions.Based on the above findings, we conclude that the damage was caused by improper handling/application and does not indicate a material or manufacturing defect.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, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a use related issue.The failure was caused by improper handling/application.If more information is provided, the case will be reassessed.

• Brand Name: HOFFMANN LRF TELESCOPIC STRUT SHORT LENGTH: 119-161MM (YELLOW)
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24257214
• Report Number: 0008031020-2026-00112
• Device Sequence Number: 18540096
• Product Code: KTT
• UDI-Device Identifier: 07613252610243
• UDI-Public: (01)07613252610243(11)250701(10)AR1414
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K233741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 49330120
• Device Lot Number: AR1414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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 Sex: Unknown