MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.4MM X 12.8MM FRTR,S; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	S-1R-G1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
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.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.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during a craniotomy surgical procedure for brain tumor removal using a cranial burr device, after closing the skull, it was observed that the tip of the burr device used for tenting was broken.It was reported that the skull was reopened, and the broken piece was retrieved from the patient.It was noted that the fragment remained in the bone, did not come in contact with the blade protecting the dura mater, and the cutting had not been made at an angle.The surgery was completed successfully with 120-minute surgical delay.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
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.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.H10 additional narrative: correction: d9: the date returned to manufacturer has been updated.Device evaluation: the actual device was returned for evaluation.An assessment was performed and the reported condition that the tip of the router used for tenting was broken was confirmed.The device was visually inspected, and it was found that the device failed visual inspection due to found corrosion on the shaft and a broken tip.The drill bit was received broken on the drilling end and appears to be corroded in some areas.It was determined that the most probable cause for the found defect was improper handling by the user due to (applied excessive force) and cutter left on devices during cleaning.The assignable root cause was determined to be traced to the user, which is user error.
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.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.H10 additional narrative: h4: the device manufacture date has been updated.

• Brand Name: 1.4MM X 12.8MM FRTR,S
• 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: 21960099
• Report Number: 1045834-2025-00292
• Device Sequence Number: 12590266
• Product Code: HBE
• UDI-Device Identifier: 00845384012627
• UDI-Public: (01)00845384012627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113476
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: S-1R-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 05/29/2025; 06/26/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/08/2025; 06/23/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown