MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2023
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(b)(6) 2023, it was reported by an arthrex employee via email that an ar-1934ps-2 peek suture tak anchor broke during insertion.This was discovered during a reconstruction of anterior talofibular ligament procedure on 6/28/2023.The case was completed using another ar-1934ps-2 peek suture tak from the same lot number.All the broken fragments were successfully retrieved.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1934ps-2 was received for investigation.Functional testing was not conducted due to the damage to the instrument.Visual evaluation found that the peek-optima bio/anchor was broken into two pieces and detached from the driver shaft.It was also noted that the sutures were frayed.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 17417508
• Report Number: 1220246-2023-07351
• Device Sequence Number: 7181670
• Product Code: HWC
• UDI-Device Identifier: 00888867024182
• UDI-Public: 00888867024182
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061863
• 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): 11/01/2024

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: SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM
• Device Catalogue Number: AR-1934PS-2
• Device Lot Number: 15047990
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 11/01/2024
• 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