MAUDE Adverse Event Report: ARTHREX, INC. SELF-PUNCHING TRIPLE LOADED FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SELF-PUNCHING TRIPLE LOADED FIBERTAK
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2024
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 04/16/2024, it was reported by a sales representative via phone that (2) ar-3633sp fibertak® sp suture anchors failed.This occurred during a rotator cuff repair on (b)(6) 2024 the first device was used and the bone had been prepped using the selfpunch and the device bent during insertion.The device was removed and the second one was brought in a punch was used to punch the whole and the device ended up pulling out.The case was completed using an ar-1927bcf-3 5.5 mm biocomposite corkscrew.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that one side of the suture anchor of the fibertak® sp suture anchor, 2.6 mm, triple loaded, with 1.3 mm suturetape (white / blue, black / white, blue) had frayed and was returned disassembled from the driver.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; and prying/leveraging the device during insertion.Per dfu-0054-eo-rev 5- g precautions-5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.8.Self-punching suture anchors only: insertion in very hard bone may require pre-punching a bone socket to avoid damage to the implant.

• Brand Name: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• 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: 19277161
• Report Number: 1220246-2024-03001
• Device Sequence Number: 7592273
• Product Code: MBI
• UDI-Device Identifier: 10888867369969
• UDI-Public: 10888867369969
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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): 09/10/2024

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: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• Device Catalogue Number: AR-3633SP
• Device Lot Number: 15188516
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2024
• 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