MAUDE Adverse Event Report: ARTHREX, INC. STEPPED, RATCHET DRILL SLEEVE; MANUAL INSTR, GENERAL SURGICAL

Model Number	STEPPED, RATCHET DRILL SLEEVE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted to provide additional information in d8/9, h3, h6: type of investigation, investigation findings, investigation conclusions, g3, and h10.Complaint allegation is confirmed.Upon visual evaluation, it was noted that the distal end of the shaft of the ratcheting drill sleeve for flipcutter®, stepped, 3.5 mm had bent.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage, as it serves as a sleeve for flipcutter® iii drills, used for various knee procedures, including acl (anterior cruciate ligament) repair.Device was manufactured 2017.
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 03/25/2024, it was reported by a sales representative via (b)(4) that an ar-1510fs-7 ratcheting drill sleeve for flipcutters tip was bent.This occurred during an acl case, making the drill hole bigger.The case continued using a different sleeve.

• Brand Name: STEPPED, RATCHET DRILL SLEEVE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 19142723
• Report Number: 1220246-2024-02158
• Device Sequence Number: 7862063
• Product Code: MDM
• UDI-Device Identifier: 00888867196766
• UDI-Public: 00888867196766
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/28/2024

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: STEPPED, RATCHET DRILL SLEEVE
• Device Catalogue Number: AR-1510FS-7
• Device Lot Number: 051730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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
• Patient Sex: Unknown