MAUDE Adverse Event Report: ARTHREX, INC. LOCK DISTAL FIBULA PLT, SS RT, 5H, STRL; BONE FIXATION PLATE

Model Number	LOCK DISTAL FIBULA PLT, SS RT, 5H, STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the context of a pseudarthrosis of a lateral malleolar fracture the implanted plate broke approximately 1 year postoperative.It was further reported that the fracture of the patient did not heal after one year and therefore a pseudarthrosis was diagnosed.It was also reported that the breakage of the plate did not occur early, as the plate was 9 months after the implantation still intact.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, d1a, d4, g3.
Event or Problem Description
Update dw 08-apr-2025: further information was provided that the initial provided part and lot number was incorrect and therefore the device information was updated.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.-upon visual inspection, and x-ray review provided noted that the locking distal fibula plate, ss, right, 5 hole, was broken off.The holes were chipped around the threads.The single-use device was used/removed and returned for investigation due to the development of pseudarthrosis at the fracture site.-dimensional inspection was conducted in accordance with drawing c18665-21, and all measured values were found to be within specified tolerances.(refer to dimension results for details.) -functional testing was not performed due to the damage to the device.Per dfu-0192-eo c.Contraindications-1.Insufficient quantity or quality of bone.2.Blood supply limitations and previous infections, which may retard healing.5.Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.E.Warnings-5.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.7.Any decision to remove the device should take into consideration the potential risk to the patient of a second surgical procedure.Device removal should be followed by adequate postoperative management.8.Detailed instructions on the use and limitations of this device should be given to the patient.G.Precautions- 4.Repeated bending of the plate at the same location, or by creating excessive acute angles may potentially lead to premature plate fatigue, failure and or breakage in situ.The most likely cause of the reported failure is patient specific effect, which involves the development of pseudarthrosis at the fracture site, which likely contributed to prolonged instability and delayed healing.This condition may have increased mechanical stress on the implant, ultimately leading to hardware fatigue and breakage, due to repeated bending of the plate at the same location, or by creating excessive acute angles that potentially lead to premature plate fatigue, failure, and or breakage in situ, and resulting in adverse patient outcomes for revision surgery.

• Brand Name: LOCK DISTAL FIBULA PLT, SS RT, 5H, STRL
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21459644
• Report Number: 1220246-2025-00647
• Device Sequence Number: 7642237
• Product Code: HRS
• UDI-Device Identifier: 00888867346895
• UDI-Public: 00888867346895
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: LOCK DISTAL FIBULA PLT, SS RT, 5H, STRL
• Device Catalogue Number: AR-8943DR-05S
• Device Lot Number: 14956105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 09/11/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 05/07/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown