MAUDE Adverse Event Report: ARTHREX, INC. DRILL ATTACHMENT - STYLE AO; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL ATTACHMENT - STYLE AO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
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 is confirmed.Upon visual evaluations of the photograph attached to the complaint of an ar-600dao -drill attachment style ao, batch number 10294342.It is concluded that the drill attachment is disassembled/damaged.Refer to the pictures attached to the complaint for further reference.The root cause of the reported failure mode is undetermined.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.
Event or Problem Description
It was reported that during a nailing surgery the attachment broke off.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: DRILL ATTACHMENT - STYLE AO
• Common Device Name: POWERED SURG ORTHOPEDIC 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: jared engle ; 8009337001
• MDR Report Key: 19454620
• Report Number: 1220246-2024-04796
• Device Sequence Number: 8545725
• Product Code: HWE
• UDI-Device Identifier: 00888867110816
• UDI-Public: 00888867110816
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: DRILL ATTACHMENT - STYLE AO
• Device Catalogue Number: AR-600DAO
• Device Lot Number: 10294342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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