MAUDE Adverse Event Report: ARTHREX, INC. CONTURLK HTO PLT,FLAT,LFT,67MM; BONE FIXATION PLATE

Model Number	CONTURLK HTO PLT,FLAT,LFT,67MM
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
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 03/17/2025, a sales representative reported via email that an ar-13730-01 contourlock hto plate, flat, 67 mm, left (from loaner set rar-13330t) was missing a bushing.The plate was implanted before they noticed it was missing a bushing.They removed the two screws that were placed and opened a new plate.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information has been received on 3/25/2025: this was discovered during an hto procedure on (b)(6) 2025.The case was completed using a new plate.The case was delayed five minutes with anesthesia for the added time.The patient did not suffer any negative effects on or after the surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-13730-01, batch 14960507, was received for investigation.- visual evaluation noted that one of the bushings was detached from the device.- functional testing was not performed due to damage to the device.- the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.- the complaint allegation is confirmed.However, the allegation that this was an 'out-of-box' occurrence can't be confirmed as the device was utilized in a procedure.- refer to investigation photos.

• Brand Name: CONTURLK HTO PLT,FLAT,LFT,67MM
• 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: 21775464
• Report Number: 1220246-2025-01244
• Device Sequence Number: 8220508
• Product Code: HRS
• UDI-Device Identifier: 00888867015142
• UDI-Public: (01)00888867015142(11)220513(17)270430(10)14960507
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• 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): 08/05/2025

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: CONTURLK HTO PLT,FLAT,LFT,67MM
• Device Catalogue Number: AR-13730-01
• Device Lot Number: 14960507
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 08/04/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/21/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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