MAUDE Adverse Event Report: ARTHREX, INC. SWVLK TENO BIO-COMP 8X 19.5MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SWVLK TENO BIO-COMP 8X 19.5MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the ar-1662bc-8 tip was broken when a screw was inserted and malleting was performed.All the broken pieces have been retrieved.Bone hole was made with an 8 mm diameter drill.Additional bone holes were created and surgery was completed using a third-party product.
Additional Manufacturer Narrative
The complaint cannot be confirmed.One unpackaged ar-1662bc-8 swivelock (no batch indicator present) was received for investigation.Visual inspection identified that the swivelock driver sleeve was not returned, along with any remnants of the reportedly broken screw.Only the inner molded assembly was received, and no abnormalities were present.Without the return of the broken screw pieces detailed in the complaint event description, the event cannot be verified.No problem found.

• Brand Name: SWVLK TENO BIO-COMP 8X 19.5MM
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11802129
• Report Number: 1220246-2021-03064
• Device Sequence Number: 1099286
• Product Code: MAI
• UDI-Device Identifier: 00888867020580
• UDI-Public: 00888867020580
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: SWVLK TENO BIO-COMP 8X 19.5MM
• Device Catalogue Number: AR-1662BC-8
• Device Lot Number: 11200078
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1