MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C, 5.5X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	PEEK SWIVELOCK C, 5.5X19.1MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the peek swivelock, ar-2323pslc, was being used in a rotator cuff surgery.The anchor broke during insertion into the bone, and the broken pieces fell into the patient¿s body.The surgeon retrieved the broken pieces using forceps, but could not retrieve all the broken pieces.The surgery was completed using a new product of the same part number.The bone quality of the patient was hard.No x-ray taken.
Additional Manufacturer Narrative
Complaint confirmed, two anchor fragments were returned wrapped in an unknown foreign substance.Likely causes of the anchor breaking include improper bone prep, misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: PEEK SWIVELOCK C, 5.5X19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10157848
• Report Number: 1220246-2020-01891
• Device Sequence Number: 14400839
• Product Code: MAI
• UDI-Device Identifier: 00888867026797
• UDI-Public: 00888867026797
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: PEEK SWIVELOCK C, 5.5X19.1MM
• Device Catalogue Number: AR-2323PSLC
• Device Lot Number: 10367466
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other