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
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	05/02/2018
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 cause of the event could not be determined from the information available and without device evaluation.
Event or Problem 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.
Additional 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
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7614027
• Report Number: 1220246-2018-00505
• Device Sequence Number: 16582972
• Product Code: MAI
• UDI-Device Identifier: 00888867026865
• UDI-Public: 00888867026865
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 10/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other