MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK SCREW, TI, 3.5X14; BONE FIXATION PLATE/SCREW

Model Number	KREULOCK SCREW, TI, 3.5X14
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/28/2025, a sales representative reported via email that two ar-8935cl-14 kreulock compression screw (3.5 mm x 14 mm) failed to engage with the locking mechanism of an ar-9943bl-04 locking distal fibula plate during an ankle fracture procedure on (b)(6) 2025.Despite proper drilling using the designated drill tower, both screws spun freely within the hole and did not lock into the plate.A 4.0 mm cortical screw was ultimately used to fill the hole; however, locking was not achieved, and they suspect that the issue is with the locking threads on the plate.Additional information has been requested on 08/01/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 08/06/2025: during a surgical procedure, they encountered an issue with the ar-9943bl-04 locking distal fibula plate (lot #15080923).While attempting to insert screws, no resistance or tactile feedback was noted.However, two ar-8935cl-14 kreulock compression screws (lot #15392704 and #15421090) failed to lock into one of the plate holes.All other holes on the plate functioned normally with similar screws.The failed screws were removed from the patient and showed signs of damage at the head.To complete the case, a 4.0 mm cortical screw, ar-8940-14 (lot #15328861) was used to fill the hole, although locking was not achieved.There was a minor delay in the procedure while a second screw was attempted, and the cortical screw was inserted.No additional anesthesia was required.Bone quality was assessed as fair, and no instruments were used to tap or prepare the bone socket.No pieces of the implant or instruments broke during the procedure, and no fragments were left behind.No adverse patient effects have been reported during or following the procedure related to this issue.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing the screw when inserting into the plate and/or hard bone.

• Brand Name: KREULOCK SCREW, TI, 3.5X14
• Common Device Name: BONE FIXATION PLATE/SCREW
• 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: 22793774
• Report Number: 1220246-2025-03466
• Device Sequence Number: 8511703
• Product Code: HRS
• UDI-Device Identifier: 00888867323063
• UDI-Public: 00888867323063
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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 Model Number: KREULOCK SCREW, TI, 3.5X14
• Device Catalogue Number: AR-8935CL-14
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 12/11/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/25/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown