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	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2023
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
On 11/14/2023, it was reported by an arthrex subsidiarity employee via email that the sutures from an ar-2371 low profile ac tightrope implant system did not go through the buttonhole.Also, the chinese finger trapped was placed in an unusual position.This was discovered during a procedure on (b)(6) 2023.Additional information received on 11/17/2023: the chinese finger trap, which is the black and white sutures, were located distal to the top hat button.This was discovered upon opening the package.The case was completed using another ar-2371 low profile ac tightrope implant system.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-2371 serial/batch number (b)(6) was received for investigation.The visual inspection revealed that the white uhmwpe braid was not included with the returned device.Additionally, it was observed that the button suture assembly system had sustained damage.Due to the device being damaged, no functional tests can be applied.The most likely cause(s) for the reported failure can be attributed to user error.According to dfu-0147.Revision 2.G.Precautions.2.Load the acl/pcl tightrope button over the un-spliced, thinner portion of the acl/pcl tightrope suture to assist assembly.Once assembled slide the acl/pcl tightrope button down to the thicker, spliced portion of the acl/pcl tightrope suture to help prevent disassembly.

• 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: 18298475
• Report Number: 1220246-2023-09330
• Device Sequence Number: 7520590
• 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): 08/26/2024

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: 15107427
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 12/10/2023
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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