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

Model Number	ACUTE AC REPAIR KIT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acromioclavicular (ac) repair surgery the wire of the device broke off.The broken off part was retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique.According to the provided information a second surgery was required.Update 01-jul-2022: it was confirmed that no revision surgery was required.
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.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation noticed that the suture lasso sd wire loop is broken at the radius area.

• 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: 14978518
• Report Number: 1220246-2022-05231
• Device Sequence Number: 14860578
• Product Code: HTN
• UDI-Device Identifier: 00888867026605
• UDI-Public: 00888867026605
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: 14913402
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown