MAUDE Adverse Event Report: ARTHREX, INC. DRILL JACOBS CHUCK 0-6.5 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL JACOBS CHUCK 0-6.5 MM
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
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.Event description: it was reported that during a cruciate ligament surgery it was noticed that the device is loose.The normal functional test of the drill attachment was performed before sterilization.No loose parts or damage were noticed.The reported event was confirmed.The suppliers evaluation revealed the locking ring which place the bearing has slipped out of the groove which loosened the bearing and allowed it to shift 3 to 4 mm.This is most likely caused by excessive pressure when drilling.
Event or Problem Description
It was reported that during a cruciate ligament surgery it was noticed that the device is loose.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update swit 04-mar-2022: the normal functional test of the drill attachment was performed before sterilization.No loose parts or damage were noticed.

• Brand Name: DRILL JACOBS CHUCK 0-6.5 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: jared engle ; 8009337001
• MDR Report Key: 19296693
• Report Number: 1220246-2024-03145
• Device Sequence Number: 15136684
• Product Code: HWE
• UDI-Device Identifier: 00888867110878
• UDI-Public: 00888867110878
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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 0-6.5 MM
• Device Catalogue Number: AR-600DJ
• Device Lot Number: 10638894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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