MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED

Catalog Number	03.503.477
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that the patient underwent mandibular tumor removal surgery.When the surgeon drilled a burr hole in the mandible for inserting a screw, the color code (light blue) of the device peeled off.The detached fragments were removed from the body, and it is unlikely that any fragments remain inside the body.The surgeon is of the opinion that no detached fragments remain inside the body.There was no problem with the drilling function of the device.The surgery was completed successfully with no surgical delay.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d9.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h6: the product was returned for device evaluation.Visual analysis of the returned sample revealed that the matrixmandible drill bit ø1.8 2flute f/0 was found missing the color code markings (light blue).Potential cause for this condition can be traced to maintenance and/or sterilization procedures, however, with available information the complete potential cause can not be determined.According to the document cleaning and sterilization instructions se_023827 rev ap the following precautions should be taken: all devices must be thoroughly cleaned and inspected prior to sterilization.Long, narrow lumens, blind holes, moving and intricate parts require particular attention during cleaning and inspection.During cleaning, only use cleaning agents that are labelled for use on medical devices and in accordance with the manufacturer¿s instructions (e.G.Temperature, contact time, and rinse time).Cleaning agents with a used dilution ph of within 7¿9.5 are recommended.Highly alkaline conditions (ph >11) can damage components/devices, such as aluminum materials.Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products).Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes.A dimensional inspection and funcional evaluation were not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the matrixmandible drill bit ø1.8 2flute f/0 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot part # 03.503.477 synthes lot # u377955 supplier lot# u377955 release to warehouse date: 11 march 2021 supplier: (b)(4) no ncrs were generated during production.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d4 (lot & exp.Date.H4 corrected: d4 (primary udi number).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH FOR 03.503.045/.047
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22629311
• Report Number: 8030965-2025-07549
• Device Sequence Number: 15765710
• Product Code: DZI
• UDI-Device Identifier: 07611819973183
• UDI-Public: (01)07611819973183(17)411231(10)U377955
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.503.477
• Device Lot Number: U377955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 08/07/2025; 08/21/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/04/2025; 08/11/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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