MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,BIO-COMP S-TAK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
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
It was reported that during a bankart and superior labrum anterior-to-posterior (slap) repair surgery the threads of the anchors ar-1934bcf-2-1 (lot: 14894159) broke.All broken parts were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Three unpackaged ar-1934bcf-2-1 sutr anch, bio-comp s-tak serial/batch number: (b)(6), were received for investigation.Visual evaluation found that devices #1 and 2 are missing the implants and the suture.However, device #3 still has attached the implant and the suture.In addition, all three devices' shafts were bent, showing scratches and signs of wear.The more in-depth visual inspection identified that device #3 implant was damaged, indicating loss of geometry and nicks.The root cause of the reported failure mode is undetermined.However, the most probable cause is applying excessive mechanical forces upon insertion/use.

• Brand Name: SUTR ANCH,BIO-COMP S-TAK
• 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: 15871191
• Report Number: 1220246-2022-05812
• Device Sequence Number: 5775470
• Product Code: MAI
• UDI-Device Identifier: 00888867097018
• UDI-Public: 00888867097018
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K140855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 12/31/2025
• Device Model Number: SUTR ANCH,BIO-COMP S-TAK
• Device Catalogue Number: AR-1934BCF-2-1
• Device Lot Number: 14894159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown