MAUDE Adverse Event Report: ARTHREX, INC. DRILL JACOBS CHUCK 0-4.0 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL JACOBS CHUCK 0-4.0 MM
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery in the traumatology the surgeon held the attachment trying to insert the drill in it instead of using the key.When powering up the handpiece, the surgeon could not hold the attachment and got the glove broken/teared.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
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.
Additional Manufacturer Narrative
The manufacturer evaluation did not reveal any problems with the device.The reported event therefore cannot be confirmed.

• Brand Name: DRILL JACOBS CHUCK 0-4.0 MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18483947
• Report Number: 1220246-2024-00235
• Device Sequence Number: 16849135
• Product Code: HWE
• UDI-Device Identifier: 00888867100091
• UDI-Public: 00888867100091
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• 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,Followup
• Report Date (Section B): 08/23/2024

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 JACOBS CHUCK 0-4.0 MM
• Device Catalogue Number: AR-300DJ
• Device Lot Number: 14948873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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
• Patient Sex: Unknown