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

Model Number ACUTE AC REPAIR KIT

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 304216351
• Report Number: 1220246-2022-05231
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867026605
• UDI-Public: 00888867026605
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUTE AC REPAIR KIT
• Device Catalogue Number: AR-2271
• Device Lot Number: 14913402
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1