MAUDE Adverse Event Report: ARTHREX INC. BIO-COMPOSITE SWIVELOCK C,CLD 4.75X19.1; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-2324BCC-1

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the screw's tip was slightly broken-off, and the tip had buckled inwards.The typical cause(s) of this type of event include turning the driver handle before the anchor body is engaged in the pilot hole, preparing a pilot hole that is too small, or inserting the implant at an angle not co-axial to the pilot hole.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that the tip of the device broke.The surgeon thinks that the tip remained inside the patient at the bottom of the bone tunnel as he did not find it.The procedure was an rotator cuff repair.The surgery was completed successfully with a new device of the same part number.

• Brand Name: BIO-COMPOSITE SWIVELOCK C,CLD 4.75X19.1
• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7230317
• MDR Text Key: 98646271
• Report Number: 1220246-2018-00023
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867097988
• UDI-Public: 00888867097988
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/31/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: AR-2324BCC-1
• Device Lot Number: 10151204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other