MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTERFSCRW W/DISP SHTH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2022
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
On (b)(6) 2022, it was reported by a sales representative via email that an ar-1370c biocomposite interference screw tip broke.Bone socket was created using 9mm pro reamer and it was of 25mm depth, the bone block was 21mm long.After reaming, the large notch was created using ar-1845 tunnel notcher for bio-interference screw.The graft was shuttled in place and a 1.1mm nitinol wire was placed followed by a universal dilator to the second line.Then, a 7mm tap was advance to a depth of 25mm.When the ar-1370c biocomposite interference screw was inserted and screwed in about 75 percent, the tip broke.Surgeon removed the screw leaving behind the tip in the tunnel.An ar-1370e sheathed cannulated interference screw was used to complete the case without further issues.This was discovered during an allograft btb acl reconstruction on (b)(6) 2022.

• Brand Name: BIO-COMP INTERFSCRW W/DISP SHTH
• Common Device Name: 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: 14075067
• Report Number: 1220246-2022-04716
• Device Sequence Number: 4807821
• Product Code: MAI
• UDI-Device Identifier: 00888867014633
• UDI-Public: 00888867014633
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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: 10/31/2025
• Device Model Number: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1370C
• Device Lot Number: 14463182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/11/2022
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown