MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPOSITE CRKSCRW 5.5X14.9MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMPOSITE CRKSCRW 5.5X14.9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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 7/30/2025, it was reported by a sales representative via email that an ar-1927bcf-3 biocomposite corkscrew failed.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 08/05/2025: during a rotator cuff repair with cuffmend augmentation on (b)(6) 2025, an ar-1927bcf-3 biocomposite corkscrew anchor was implanted in the medial row.While tying knots, the surgeon felt a ¿pop¿ and noticed the fixation had loosened.Investigation revealed the anchor was still intact in the bone, but the suture had pulled out of the anchor.No excessive force or unusual activity occurred during implantation.The anchor was removed using the spent inserter.It appeared that an internal component had broken.After inspecting the joint space, no fragments were found.A second ar-1927bcf-3 anchor from the same lot was implanted into the original hole and functioned as intended.The case was delayed for less than 10 minutes to remove the failed anchor and implant the second, requiring minimal additional anesthesia.No photos were taken.Additional information was received on 08/12/2025: the original implant bone socket was prepared by using the standard, silver 5.5 corkscrew punch, ar-1927pb.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the 5.5 mm biocomposite corkscrew® ft tripleplay®, identified that there was no presence of the anchor on the tripleplay anchor sub-assembly, the anchor was broken off.A black/white suture tape was returned with the device; however, it is not a component of ar-1927bcf-3.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: BIO-COMPOSITE CRKSCRW 5.5X14.9MM
• 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: 22814364
• Report Number: 1220246-2025-03506
• Device Sequence Number: 17590112
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: (01)00888867023369(11)250210(17)290131(10)15386584
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• 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,Followup
• Report Date (Section B): 11/20/2025

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: BIO-COMPOSITE CRKSCRW 5.5X14.9MM
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 15386584
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown