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

Model Number	ACUTE AC REPAIR KIT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint is confirmed based on the customer-provided photo, which displays the increased gap in the buttons.However, without the return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.
Event or Problem Description
It was reported on (b)(6) 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 planned for (b)(6) 2022.Updated revision surgery rescheduled to (b)(6) 2022.Per facility: "patient had an acute grade 3 disruption of his acj on (b)(6) 2022 following a fall off of his bike.He 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 manufacturer's recommendation and active physiotherapy exercises where started at this stage.The reduction of the acj at the six-week mark was still excellent although a few millimeters of loss of reduction was noted.At six weeks post-surgery, once the reduction is well maintained, as is my normal practice, the patient was discharged from my care and left in the hands of the therapist.This visit occurred on (b)(6) 2022.Patient was advised on active range of motion but to avoid heavy lifting for another 6 weeks.Following this visit, the patient progressed well, returning to cycling although complain of the occasional twinge of pain with certain activities.In late august he noted an increases deformity of the acj and x-rays confirmed that the acj reduction had displaced by 100 %, returning to his pre-injury state.The dog bone buttons were still in place and there was no evidence of ¿cut out¿ or fractures around the dog bone." additional information received on 3/3/2023: patient underwent revision surgery on (b)(6) 2022.The fibertape and top button from an ar-2271 acute ac repair implant system were explanted, and the lower button remains in the patient as surgeon could not retrieve it.Case was complete with (2) ar-1655ps peek tenodesis screw, and an ar-1676ds bio-tenodesis disposable kit was used to implant the screws.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 16597087
• Report Number: 1220246-2023-06470
• Device Sequence Number: 14847059
• 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
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/23/2023

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: ACUTE AC REPAIR KIT
• Device Catalogue Number: AR-2271
• Device Lot Number: 14913402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/23/2023
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown