MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/23/2021 , it was reported by an arthrex employee via email that an ar1320bcnf suturetak anchor was implanted and the inserter shaft got stuck to the implant.This was discovered during ankle ligament repair and internal fixation procedure on (b)(6) 2021.Because the shaft could not be taken out, the implant broke.Surgeon completed procedure by opening a new ar-1320bcnf suturetak from a different lot number.
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 11/23/2021 , it was reported by an arthrex employee via email that an ar1320bcnf suturetak anchor was implanted and the inserter shaft got stuck to the implant.This was discovered during ankle ligament repair and internal fixation procedure on (b)(6) 2021.Because the shaft could not be taken out, the implant broke.Surgeon completed procedure by opening a new ar-1320bcnf suturetak from a different lot number.
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.
Additional Manufacturer Narrative
The complaint is unable to be confirmed.One unpackaged ar-1320bcnf inserter and associated suture constructs were received for investigation.Visual inspection identified that the biocomposite anchor was not returned with the remainder of the assembly, and as such, was not able to be verified as stuck at the distal end of the inserter.Suture fraying was present at the distal ends of both the white and blue suture constructs.The cause remains undetermined.

• Brand Name: SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
• 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: 12984975
• Report Number: 1220246-2021-04113
• Device Sequence Number: 11939977
• Product Code: MAI
• UDI-Device Identifier: 00888867009813
• UDI-Public: 00888867009813
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140855
• 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): 02/11/2022

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: 08/31/2024
• Device Model Number: SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
• Device Catalogue Number: AR-1320BCNF
• Device Lot Number: 11653579
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown