MAUDE Adverse Event Report: ARTHREX, INC. 4.5MM QUICK RELEASE DRILL; MANUAL INSTR, GENERAL SURGICAL

Model Number	4.5MM QUICK RELEASE DRILL
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure is wear and tear.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).
Event or Problem Description
On 08/22/2022, it was reported by a sales representative via sems that ar-9239 4.5mm quick release drill had an issue.During a total shoulder replacement on 08/22/2022, it totally stripped the drill - no flutes left upon normal use.The case was successfully completed without incidence, there was no harm and no piece broke off inside the patient.This was discovered during use with no impact to the patient.

• Brand Name: 4.5MM QUICK RELEASE DRILL
• 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: 19370156
• Report Number: 1220246-2024-03639
• Device Sequence Number: 7538018
• Product Code: MDM
• UDI-Device Identifier: 00888867059528
• UDI-Public: 00888867059528
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: 4.5MM QUICK RELEASE DRILL
• Device Catalogue Number: AR-9239
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown