MAUDE Adverse Event Report: Arthrex, Inc. Locking Third Tubular Plate, Ti, 8H; BONE FIXATION PLATE

Model Number	Locking Third Tubular Plate, Ti, 8H
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10-aug-2026, a sales representative reported via email that an ar-9943t-08 locking third tubular plate, 8 hole, was involved in an event.During a distal fibula fracture revision procedure performed on (b)(6) 2026, a tightrope pro was used in conjunction with the plate.It was reported that the tightrope pro slipped through the plate's oblong hole, resulting in loss of fracture reduction (malreduction).An immediate revision was performed, during which the tightrope pro was removed, and a 4.0 × 16 mm cancellous screw was implanted for fixation, allowing successful realignment and reduction of the fracture.The patient outcome was not reported.Additional information was received on 19-aug-2026: the sales representative reported that the ar-9925t syndesmosis tightrope pro implant was used in conjunction with the plate.The tightrope pro was intentionally implanted through the third hole from the most distal end of the plate.Initial intraoperative imaging reportedly demonstrated an acceptable reduction.However, approximately four hours after wound closure, postoperative radiographs obtained in recovery identified a malreduction.The surgeon's assessment was that the tightrope pro had been placed through a plate hole for which it was not indicated, allowing the lateral button to pull through the oblong hole and seat against the bone.The implant was not reported to be damaged or broken.The patient underwent revision surgery the morning following the index procedure.During the revision, the tightrope pro was removed, while the ar-9943t-08 locking third tubular plate remained implanted.An ar-8940-16 low profile screw, non-locking, 4.0 x 16 mm was implanted through the oblong hole in place of the tightrope pro to reduce the fracture and correct the valgus alignment.No device fragments were retained in the patient.The sales representative reported that the procedure was not delayed, no additional anesthesia was administered during the original procedure, and no instrument was used to prepare a bone socket for implant insertion.Bone quality was described as adequate.No adverse patient outcome was reported other than the revision surgery, and no additional revision procedures or treatments have been required since the event.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Locking Third Tubular Plate, Ti, 8H
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50472272
• Report Number: 1220246-2026-04501
• Device Sequence Number: 18708173
• Product Code: HRS
• UDI-Device Identifier: 00888867256187
• UDI-Public: 00888867256187
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111253
• 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
• Report Date (Section B): 08/27/2026

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: Locking Third Tubular Plate, Ti, 8H
• Device Catalogue Number: AR-9943T-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/27/2026
• 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: Other
• Patient Sex: Unknown