MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MINI BC S-TAK 2.4X 8.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via (b)(6) that a ar-1322bcnf suture anchor broke.This occurred during use, upon insertion the sutures immediately broke through the inner rig of the anchor.The case was completed successfully using a new anchor of the same part number and different lot number.There was no patient effect reported.
Additional Manufacturer Narrative
Complaint not confirmed, the device was returned without suture.The allegation could not be observed.
Additional Manufacturer Narrative
Complaint not confirmed, the device was returned without suture.The allegation could not be observed.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via (b)(6) that a ar-1322bcnf suture anchor broke.This occurred during use, upon insertion the sutures immediately broke through the inner rig of the anchor.The case was completed successfully using a new anchor of the same part number and different lot number.There was no patient effect reported.

• Brand Name: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• 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: 12915370
• Report Number: 1220246-2021-04036
• Device Sequence Number: 4517482
• Product Code: MAI
• UDI-Device Identifier: 00888867010147
• UDI-Public: 00888867010147
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140855
• 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): 12/02/2021

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: 01/31/2024
• Device Model Number: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• Device Catalogue Number: AR-1322BCNF
• Device Lot Number: 10654539
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown