MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number BIO-COMP SWVLK SP, 4.75X24.5MM

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

Patient Problems Failure of Implant (1924); Rupture (2208)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during a rupture of the supraspinatus tendon the swivelock broke off when turning in.***update smer 12 june 2018: the surgery was completed successfully with a new device of the same part number.The new device was placed on a different spot - it is not covering the broken anchor.The anchor broke and 2/3 of the anchor will remain inside the bone well fixed.

Manufacturer Narrative

Complaint confirmed.Visual evaluation of the returned ar-2324bcm revealed that the swivelock screw had fragmented at the sixth distal thread.The most likely cause(s) of this type of event include advancing the implant before the driver tip has been driven to the proper depth or prying and/or leveraging the driver.

• Brand Name: BIO-COMP SWVLK SP, 4.75X24.5MM
• 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: 7614027
• MDR Text Key: 111483902
• Report Number: 1220246-2018-00505
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026865
• UDI-Public: 00888867026865
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BIO-COMP SWVLK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: F159278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other