MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.85MM X 16 MM FRTR,CRNA; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	A-CRN-G1
Medical Device Problem Codes	Material Fragmentation (1261); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the 1.85mm x 16 mm frtr, crna device broke into two pieces (fractured).It was reported in the service order that the user was unable to remove the cutter device.It was unknown when the event occurred.There were no reports of delays to a surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2025.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: the device was functionally / visually tested.The described failure by the customer was confirmed.The device was visually inspected as received from the customer.It was found that the device failed visual inspection due to the fact that it was received stuck to the attachment and found corrosion.The drill bit was received stuck to the attachment.The attachment had to be disassembled to remove the drill bit.The drill bit showed corrosion on the shafts connection points where it was attached to the attachment.This can happen when the device is getting washed- user error.Furthermore, it was detected that the drill bit was fractured.Root cause comments: the most probable cause for the found defect is user error.As part of synthes quality process all devices are manufactured, inspected, and released to approved specifications.The ifu states the following regarding the reported issue that was observed by the user or customer: synthes recommends using a new cutting tool for each operation and discarding it after use.Cutting tools intended for single-use must not be reused.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review no manufacturing record evaluation required as no manufacturer or service-related issue found.

• Brand Name: 1.85MM X 16 MM FRTR,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: elba bello ; 4500 riverside drive; palm beach gardens, FL 33410 ; 9083863534
• MDR Report Key: 24190821
• Report Number: 1045834-2026-00028
• Device Sequence Number: 9600309
• Product Code: HBE
• UDI-Device Identifier: 00845384012603
• UDI-Public: (01)00845384012603(10)W013161829
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/27/2026

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 Catalogue Number: A-CRN-G1
• Device Lot Number: W013161829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown