MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2024
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
On 9th may 2024, it was reported by an arthrex employee via email that for an ar-1320bcnf, suture anchor, micro biocomposite suturetak® 2.4 x 6.5 mm with 2-0 fiber wire® with two taper point needles, the anchor was broken during insertion.This was detected during use in an ankle ligament repair procedure on (b)(6) 2024.The procedure was completed successfully as another brand's product was used.Pieces broke inside the patient but all fragments were retrieved.No patient harm and no secondary procedure were needed.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, suture anchor, micro biocomposite suturetak, ar-1320bcnf/ batch 15096527, inserter and associated suture constructs were received for investigation.Visual inspection identified that the bio-composite anchor threads were damaged.Suture fraying was present on the blue suture constructs.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 19454083
• Report Number: 1220246-2024-04788
• Device Sequence Number: 15593146
• 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): 09/24/2024

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 Model Number: SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
• Device Catalogue Number: AR-1320BCNF
• Device Lot Number: 15096527
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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