MAUDE Adverse Event Report: ARTHREX, INC. ACUTE AC REPAIR KIT; WASHER, BOLT NUT

Model Number	ACUTE AC REPAIR KIT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 09/06/2022 by a customer via email that an ar-2271 dog bone system has displaced and requires a revision surgery.This was discovered after use.Revision surgery scheduled for (b)(6) 2022.Revision surgery postponed to a later date.Per facility: " patient had surgery under my care to reconstruct his acj on (b)(6) 2022.An arthroscopically assisted reconstruction using the arthrex tight rope/ dog bone technique was used.Surgery was uneventful and post operative x-rays showed a good position of the dog bone buttons and an excellent reduction of the acj.The patient was kept in a sling for 6 weeks as per the manufacturers recommendation allowing assisted range of motion exercises of the shoulder.Active physiotherapy exercises was started after this.The reduction of the acj at the six week mark was still excellent although a few millimetres of loss of reduction was noted.His post operative recovery was uneventful and he regained full range of motion of his shoulder with the aid of the physiotherapist.He was discharged from my clinic on (b)(6) 2022 when post operative x-rays showed a well maintained reduction.In late august he noted an increases deformity of the acj and x-rays confirmed that the acj reduction had displaced by more than 100 %.The dog bone buttons were still in place and there was no evidence of ¿cut out¿ or fractures around the dog bone.".
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed based on the customer provided photo, which displays the displaced dog bone buttons.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: ACUTE AC REPAIR KIT
• Common Device Name: WASHER, BOLT NUT
• 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: 19164183
• Report Number: 1220246-2024-02248
• Device Sequence Number: 7855544
• Product Code: HTN
• UDI-Device Identifier: 00888867026605
• UDI-Public: 00888867026605
• Combination Product (Y/N): N
• Initial Reporter Country: TD
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: ACUTE AC REPAIR KIT
• Device Catalogue Number: AR-2271
• Device Lot Number: 14656694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown