MAUDE Adverse Event Report: ARTHREX, INC. INTERFERENCE SCREW INSERTION KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	INTERFERENCE SCREW INSERTION KIT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament (acl) reconstruction surgery with btb graft + fastthread interference screws, the surgeon used the interference screw insertion kit to insert the fast thread screw (9mm x 30mm).He did drill the wire beyond the depth marking relative to the black handle on the insertion kit dilator device.The surgeon withdrew the screw driver and attached the wire driver to remove the wire.The torsion must have broken the wire.Surgeon tried to pull the broken portion of the wire directly out with pliers.This portion of wire broke again resulting in the remining piece remaining in situ within the patients femur.It was decided to leave it and complete the case.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
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.
Additional Manufacturer Narrative
Complaint confirmed, even though the device was not returned, an x-ray was provided which shows what may be a fragment from a wire.It is not possible to confirm this is a fragment from the nitinol wire c15419 included in the ar-1249tk kit.

• Brand Name: INTERFERENCE SCREW INSERTION KIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13757840
• Report Number: 1220246-2022-04591
• Device Sequence Number: 4990400
• Product Code: LXH
• UDI-Device Identifier: 00888867292260
• UDI-Public: 00888867292260
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 03/31/2023
• Device Model Number: INTERFERENCE SCREW INSERTION KIT
• Device Catalogue Number: AR-1249TK
• Device Lot Number: 10204577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 06/03/2022
• Date Device Manufactured: 04/18/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown