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

Model Number	STEPPED, RATCHET DRILL SLEEVE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/21/2022, it was reported by a sales representative via sems that a ar-1510fs-7 ratchet drill sleeves top popped off, making the guide unusable.This occurred on (b)(6) 2022 during an unknown case, with no patient effect reported.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.Upon visual inspection it was noted that the head of the guide is detached.This matches an older version of the product (rev.4).A one-piece construction (rev.5) was introduced with eco-15510.

• 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: 19309393
• Report Number: 1220246-2024-03228
• Device Sequence Number: 19608569
• Product Code: MDM
• UDI-Device Identifier: 00888867196766
• UDI-Public: 00888867196766
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 151744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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