MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK SP, 5.5X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP SWIVELOCK SP, 5.5X24.5MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that a ar-2323bcm suture anchor broke.This occurred on (b)(6) 2021 during a procedure when the surgeon was inserting the anchor the biocomposite section of the anchor broke.The bone quality of the patient was good, but not extremely hard.There was no patient effect reported.Additional information requested.Additional information provided on 12/01/2021 : the procedure being performed was a rotator cuff.The device broke during the procedure, and all fragments were removed.No instrument was used to prepare the bone socket as the 2323bcm is self punching.The case was completed using a ar-2323bct-2.
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.

• Brand Name: BIO-COMP SWIVELOCK SP, 5.5X24.5MM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13471113
• Report Number: 1220246-2022-04395
• Device Sequence Number: 16572453
• Product Code: MAI
• UDI-Device Identifier: 00888867026735
• UDI-Public: 00888867026735
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 01/31/2025
• Device Model Number: BIO-COMP SWIVELOCK SP, 5.5X24.5MM
• Device Catalogue Number: AR-2323BCM
• Device Lot Number: 12791785
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 02/07/2022
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown