MAUDE Adverse Event Report: ARTHREX, INC. LOW-PROFILE AC IMPLANT DEVICE; WASHER, BOLT NUT

Model Number	LOW-PROFILE AC IMPLANT DEVICE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the tightening suture of the device broke on the collarbone side during an acromioclavicular repair surgery.The broken piece 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 or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation showed that the fiberlink ends are frayed and tigerlink has returned in three pieces, all ends are frayed.Also, the top hat button was not returned.The cause is undetermined, however a likely cause is user-applied excessive forces.

• Brand Name: LOW-PROFILE AC IMPLANT DEVICE
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12076084
• Report Number: 1220246-2021-03331
• Device Sequence Number: 19759104
• Product Code: HTN
• UDI-Device Identifier: 00888867224247
• UDI-Public: 00888867224247
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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 Expiration Date: 04/30/2025
• Device Model Number: LOW-PROFILE AC IMPLANT DEVICE
• Device Catalogue Number: AR-2370
• Device Lot Number: 11039542
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 09/22/2021
• Patient Sequence Number: 1