MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 2.15MM X 22MM SRTR,CRNA; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	A-CRN-S-G1
Medical Device Problem Codes	Dull, Blunt (2407); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was by united states reported that during service and evaluation, it was determined that the cutter device was found to be dull/would not cut.It was noted in the service order that the saw device (cutter) was stuck in the attachment device.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: device evaluation: the actual device was returned for evaluation.During evaluation, it was observed that the cutter device and craniotome attachment device were received stuck together.Once the devices were disassembled, it was observed that there were heavy signs of usage.It was further observed that the devices were covered with foreign substance and corrosion.The device also failed pretest for visual inspection.Therefore, the reported condition that the device was dull/not cutting identified during service and evaluation was confirmed.The assignable root cause of the dull cutter was determined to be traced to component failure from wear.The remaining failures were determined to be due to environmental factors.Udi: (b)(4).

• Brand Name: 2.15MM X 22MM SRTR,CRNA
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 14575128
• Report Number: 1045834-2022-00647
• Device Sequence Number: 17670554
• Product Code: HBE
• UDI-Device Identifier: 00845384012597
• UDI-Public: 00845384012597
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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 Expiration Date: 06/13/2026
• Device Model Number: A-CRN-S-G1
• Device Catalogue Number: A-CRN-S-G1
• Device Lot Number: R253146796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown