MAUDE Adverse Event Report: STRYKER GMBH WIRE WITH OLIVE, DIAMOND POINT HOFFMANN LRF Ø1.8 X 450MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49338030
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported by the customer that there were four wire breakages on a frame.The wires broke at the interface with the wire bolt.The primary surgery was completed successfully.The patient was weight bearing and there were no falls or trips to cause the reported event.During the revision surgery it was reported that another wire in the proximal ring at the olive broke.
Event or Problem Description
It was reported by the customer that there were four wire breakages on a frame.The wires broke at the interface with the wire bolt.The primary surgery was completed successfully.The patient was weight bearing and there were no falls or trips to cause the reported event.During the revision surgery it was reported that another wire in the proximal ring at the olive broke.
Additional Manufacturer Narrative
Correction to d9 (product available to stryker) and h6(device code).The complaint couldn't be confirmed, since the returned image for evaluation don't matches the alleged failure.The investigation revealed the following: following our inspection of the x-ray images, we can confirm that one wire is no longer connected to the wire bolt.However, it is not possible to determine from the images whether the wire is broken or simply disconnected.No other abnormalities are visible.For a comprehensive evaluation, we kindly request that the material be returned to us.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: WIRE WITH OLIVE, DIAMOND POINT HOFFMANN LRF Ø1.8 X 450MM
• 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: 23005063
• Report Number: 0008031020-2025-01468
• Device Sequence Number: 9847991
• Product Code: KTT
• UDI-Device Identifier: 07613252611011
• UDI-Public: 07613252611011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K233741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 49338030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Unknown
• Patient Weight: 72 KG