MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C,4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number PEEK SWIVELOCK C,4.75X19.1MM

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, it was reported by a sales representative via email that (2) ar-2324pslc swivelock broke prematurely leaving only a few threads in the bone.This was discovered during an achilles procedure.Surgeon completed procedure using a 5.5 metal anchor.After receiving additional information on 12/10/2021, sales representative has confirm that both anchors broke inside the patient and the fragments that were not stuck on the bone, were removed; however, the pieces of anchors that were implanted, surgeon left them inside the patient.Surgeon completed the procedure by implanting ar-1928sf-3 corkscrew suture anchor next to the failed anchor pieces that were not removed.

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.

• Brand Name: PEEK SWIVELOCK C,4.75X19.1MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13087846
• MDR Text Key: 286648231
• Report Number: 1220246-2021-04199
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: 00888867026919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 13734437
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2021
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1