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

Model Number	LOCK DISTAL FIBULA PLT, SS RT, 5H
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/1/2023, it was reported by a sales representative via email that the distal locking screw would not lock into an ar-8943dr-05 right locking distal fibula plate.No additional information was provided.Additional information received on 11/2/2023: this was discovered during an open reduction internal fixation of the ankle.Two ar-8827cl-12 kreulock compression screw and an ar-8827cl-16 kreulock compression screw did not lock into the plate.The case was completed using one of the ar-8827cl-12 kreulock compression screws, other larger screws, and a new ar-8943dr-05 right locking distal fibula plate.Per the sales representative, the distal locking holes looked off, and although it was hard to tell if it was before inserting the screws, but the locking tower was having difficulty locking onto the plate in the correct trajectory.Added the peek aiming guide onto the plate to get the correct trajectory, and the locking tower was still having difficulty threading into the plate and as well as having the screws seat properly.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: LOCK DISTAL FIBULA PLT, SS RT, 5H
• 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: emily shafer ; 8009337001
• MDR Report Key: 18221386
• Report Number: 1220246-2023-08949
• Device Sequence Number: 20251772
• Product Code: HRS
• UDI-Device Identifier: 00888867346895
• UDI-Public: 00888867346895
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123241
• 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): 11/28/2023

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: LOCK DISTAL FIBULA PLT, SS RT, 5H
• Device Catalogue Number: AR-8943DR-05
• Device Lot Number: 105642310
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2023
• 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
• Patient Sex: Unknown