MAUDE Adverse Event Report: ARTHREX, INC. LOCKING GUIDE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	LOCKING GUIDE
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/20/2023
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 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 during a meniscal root repair surgery on two separate attempts the drill came out 5mm medially from the point at which it should have come out as indicated by the 7.5mm offset mark on the hook.This led to an unnecessary loss of tibia bone in the patient.The surgery was finished successfully with a different device (ar-1610lg).It was necessary to use the tibia acl (halo) jig to accurately drill the tibia tunnel.Update (b)(4) 11-jan-2024: further information revealed that ar-1610lg batch: 43212209 was also involved in this incident.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Complaint is not confirmed.Functional testing of the meniscal root locking guide was performed with the matting part returned ar-1610mr.The device worked as required without any issues.No problem was found with the device.Visual inspection identified the laser marks had faded.Also, it shows rust around the locking guide surface.No problem found.

• Brand Name: LOCKING GUIDE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18666667
• Report Number: 1220246-2024-00843
• Device Sequence Number: 7070963
• Product Code: MDM
• UDI-Device Identifier: 00888867241947
• UDI-Public: 00888867241947
• 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): 04/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LOCKING GUIDE
• Device Catalogue Number: AR-1610LG
• Device Lot Number: 43212209
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown