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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
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 that two broken 1.8mm olive wires in proximal ring of hlrf frame.Immediate full weight bearing on right side (frame side).Non weight bearing on left side one at hlrf wire bolt interface and one in the bone.Patient noticed first broken wire at home on (b)(6).Patient phoned surgeon and was advised nwb and to come straight to clinic.Patient attended clinic that afternoon and second broken wire was identified.Patient returned to theatre, the two broken wires were removed and replaced with three new wires.Wire lot numbers are not available as this section of the wire was cut off and discarded when cutting to length during initial build no bone quality concerns and patient has type 2 diabetes.
Additional Manufacturer Narrative
Correction to g4(pma/510(k), h3 (device evaluated by mfg), h6 (device code) to remove break code.The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The investigation revealed the following: visual examination of the received product shows that the wire is broken as reported.On one side there are marks visible from the wire bolt, on the other side the wire is broken.The part will be forwarded for further evaluation.Mechanical engineering reviewed the images and noted: wire with black marks: conclusion: fatigue failure mode is detected.During the surgery: the torque applied to wire bolt 2 during the wire tensioning step was too high (finger tightening is recommended).This overtightening increases friction and changes the real tension in the wire, as shown on the tensioner scale, which reduces its fatigue resistance.During treatment of patient: no wire slippage was observed (which can happen during the treatment) on both wire bolt.Remark: the absence of the second segment of wire doesn¿t influence the analysis.The missing information about which wire bolt was connected to the wire doesn¿t influence the analysis.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 most likely by to much tightening before final tensioning, as fatigue resistance got reduced.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that two broken 1.8mm olive wires in proximal ring of hlrf frame.Immediate full weight bearing on right side (frame side).Non-weight bearing on left side one at hlrf wire bolt interface and one in the bone.Patient noticed first broken wire at home on (b)(6).Patient phoned surgeon and was advised (b)(6) and to come straight to clinic.Patient attended clinic that afternoon and second broken wire was identified.Patient returned to theatre, the two broken wires were removed and replaced with three new wires.Wire lot numbers are not available as this section of the wire was cut off and discarded when cutting to length during initial build.No bone quality concerns and patient has type 2 diabetes.

• 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: 22949694
• Report Number: 0008031020-2025-01439
• Device Sequence Number: 20933839
• Product Code: KTT
• UDI-Device Identifier: 07613252611011
• UDI-Public: (01)07613252611011(11)250203(10)30707K
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113327
• 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): 12/05/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 99 KG