MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK, 3.9X17.9MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK, 3.9X17.9MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/10/2024, it was reported by a sales representative via phone that an ar-2326pslc peek swivelock suture anchor had an issue.During a rotator cuff repair procedure on (b)(6) 2023, the eyelet of the anchor would not come off; it was stuck on the device.Nothing broke inside the patient, and the surgeon removed everything from the patient in one piece with no harm to the patient.An ar-2324pslc suture anchor, peek-swivelock, with lot number 15221727, was used to complete the case successfully.The complaint device was available for return.There was no case delay, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
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
Additional information: d9, g3, h3, h6 the complaint allegation is not confirmed.One unpackaged, ar-2326pslc, serial/batch 15212978, was received for investigation.Upon visual evaluation, no problems were noted with the exterior of the device.Functional testing found that the anchor moved smoothly in and out and the eyelet could be removed and put back on without any issues.No problem found.

• Brand Name: PEEK SWIVELOCK, 3.9X17.9MM
• 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: 19674250
• Report Number: 1220246-2024-06586
• Device Sequence Number: 12632405
• Product Code: MAI
• UDI-Device Identifier: 00888867289154
• UDI-Public: 00888867289154
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 09/26/2024

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: PEEK SWIVELOCK, 3.9X17.9MM
• Device Catalogue Number: AR-2326PSLC
• Device Lot Number: 15212978
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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