MAUDE Adverse Event Report: ARTHREX, INC. FASTTHREAD INTERFERENCE SCREW TAP, 7MM; BIT, DRILL

Model Number	FASTTHREAD INTERFERENCE SCREW TAP, 7MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/22/2022, it was reported by a distributor via sems that ar-4020ht-07 fastthread screw tap shredded the suture tape upon tapping the tibial tunnel.At this point, the graft was already fixed on the femur, so surgeon was left to pass a 22 gage wire through the tibial bone block before attaining tension once more and fixating the graft.This added 20 minutes to the surgery and additional anesthesia was administered to the patient.Tap handle broke form the tap shaft during the tapping of the femoral acl socket.All broken pieces were retrieved.This was discovered during an anterior cruciate ligament reconstruction, bone patellar bone technique of the left knee on (b)(6) 2022.
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.

• Brand Name: FASTTHREAD INTERFERENCE SCREW TAP, 7MM
• Common Device Name: BIT, DRILL
• 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: 15223650
• Report Number: 1220246-2022-05356
• Device Sequence Number: 5977518
• Product Code: HTW
• UDI-Device Identifier: 00888867291980
• UDI-Public: 00888867291980
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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): 08/15/2022

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 Model Number: FASTTHREAD INTERFERENCE SCREW TAP, 7MM
• Device Catalogue Number: AR-4020HT-07
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown