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

Model Number	LOW-PROFILE AC REPAIR SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 06/15/2023, it was reported by an arthrex employee via sems that the 3mm hollow drill included in the ar-2371 low profile ac tightrope® implant system, did not pass smoothly through the ar-2255cg-05 and broke off.A new device was used to complete the case with no patient harm.Additional information received 6/21/2023: the event occurred during an acromioclavicular joint dislocation repair procedure.The broken pieces were on the extracorporeal side and retrieved without incident and the one stuck in the drill was extracted per guide.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-2371 was received for investigation.A drill that doesn't belong to the complaint was received.Functional testing was not conducted due to the damage to the returned instruments.Visual evaluation of the three returned found that the 3 mm drill is missing the tip.It was also noted scratches lines around the outer diameter.The inner shaft trocar point tip was broken.An unknown part number drill was received with the compliant devices.Visual evaluation of this part found that the device's tip was bent and twisted.Also, the drill was damaged at the proximal end, missing the connector.The most likely cause for the reported failure can be attributed to applying excessive forces through leveraging/prying the device.

• Brand Name: LOW-PROFILE AC REPAIR SYSTEM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17270252
• Report Number: 1220246-2023-07063
• Device Sequence Number: 20348346
• Product Code: HTN
• UDI-Device Identifier: 00888867256637
• UDI-Public: 00888867256637
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/31/2024

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: LOW-PROFILE AC REPAIR SYSTEM
• Device Catalogue Number: AR-2371
• Device Lot Number: 15047622
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown