MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTURE ANCHOR, CORKSCREW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 3rd july 2025, it was reported by an arthrex's employee via email that for an ar-1920sf, suture anchor, corkscrew® 5 mm x 15.5 mm with #2 fiberwire® and #2 tiger wire®, its anchor broke during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2025.The procedure was completed successfully by using another brand products.There was no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1920sf batch 15203467 was received for evaluation.Visual inspection of the received device noted that the anchor is securely attached to the sutures.No damage was observed on the inserter or handle.Further evaluation was conducted by measuring the anchor according to drawing c1987 at revision 5: overall length.610 +.020/-.000 inches.Results: 0.617 inches.The device is within the tolerance.Functional testing was not performed; however, the sutures attached to the anchor were moved without any resistance.The most likely cause of the reported failure is user error, including improper bone preparation, misalignment of the insertion, and/or prying/leveraging the device during use.Conclusion: the anchor and or other components were not broken or damaged; however, the anchor was received outside of the shaft, which may be the basis for the reported allegation of breakage.

• Brand Name: SUTURE ANCHOR, CORKSCREW
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 22608805
• Report Number: 1220246-2025-03081
• Device Sequence Number: 13152797
• Product Code: MBI
• UDI-Device Identifier: 00888867022829
• UDI-Public: (01)00888867022829(11)240206(17)290131(10)15203467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061863
• 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): 09/30/2025

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: SUTURE ANCHOR, CORKSCREW
• Device Catalogue Number: AR-1920SF
• Device Lot Number: 15203467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown