MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FLUTED BALL, 15CM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	MA15-3SB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the demo, the 3mm fluted ball, 15cm burr device was broken off.No additional information could be provided.
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
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 received photo was reviewed.The described failure by the customer was confirmed.The received photo was reviewed and compered to a known good unit.It was found that the device failed visual inspection due to broken cutter and found corrosion.Based on the provided photo it shows signs of corrosion on the tip of the cutter and at the breaking point of the shaft.The most relevant root cause is linked to improper handling.As part of anspach quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use states the following regarding the reported issue that was observed by the user or customer: anspach cutting tools are designed for single use only.Do not force the cutting burrs while performing operation.Use a gentle tapping motion or side to side motion and let the instrument do the cutting.Forceful side loading of cutting burrs may cause fracture of dissecting tool, which may cause injury.Products intended for single-use must not be re-used.Re-use or reprocessing (e.G.Cleaning and resterilization) may compromise the structural integrity of the device and/or lead to device failure additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: 3MM FLUTED BALL, 15CM
• 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: 24013150
• Report Number: 1045834-2026-00013
• Device Sequence Number: 10595161
• Product Code: HBE
• UDI-Device Identifier: 00845384004554
• UDI-Public: (01)00845384004554(10)U163155627
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: MA15-3SB
• Device Lot Number: U163155627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown