MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On(b)(6) 2023, it was reported by an arthrex employee via email that an ar-2324bcctt biocomposite swivelock anchor broke during insertion and the sutures dropped off.The case was completed using another ar-2324bcctt biocomposite swivelock.This was discovered during a procedure on (b)(6) 2023.Additional information requested.Additional information provided (b)(6) 2023: the procedure performed was a rotator cuff.The suture loosen and then came apart.All broken fragments were removed and the case was completed using another ar-2324bcctt biocomposite swivelock.
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.
Additional Manufacturer Narrative
The complaint allegation was confirmed.(1) unpackaged ar-2324bcctt was returned for investigation.The returned devices were visually inspected, and it was noted no issues.Functional test of the driver outer sleeve and the tb inner member molded swivelock found that the devices thread smoothly.Per event description, "ar-2324bcctt biocomposite swivelock anchor broke during insertion and the sutures dropped off." is concluded that the anchor was damaged during the insertion.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 17269295
• Report Number: 1220246-2023-07057
• Device Sequence Number: 12239990
• Product Code: MAI
• UDI-Device Identifier: 00888867026858
• UDI-Public: 00888867026858
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101823
• 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): 09/17/2024

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 Expiration Date: 08/31/2025
• Device Model Number: BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM
• Device Catalogue Number: AR-2324BCCTT
• Device Lot Number: 14139812
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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