MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE 1.5MM DRILL BIT MQC/125MM F/03.503.045/047; DRILL, BONE, POWERED

Catalog Number	03.503.479
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the surgeons were in an open repair of parasymphyseal fracture case.The doctor had used the drill bit and the tip broke and unfortunately stuck on the mandible of the patient.The doctors mentioned that they would have to crack open the mandible to retrieve the drill bit.The doctors did disclosure to patient and did the necessary documentation of the 2.5cm drill bit tip stuck on the mandible.Procedure was completed successfully.The fragment was left in situ.Surgical delay was unknown.
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 medwatch, a follow-up medwatch 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: photo investigation the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that drill bit ø1.5 f/matmand l125 2flute f/0 had broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.The investigation was not able to confirm the allegation of embedded device as no x-rays were provided to evaluate the condition.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the drill bit ø1.5 f/matmand l125 2flute f/0 would contribute to the complained device issue.Based on the investigation findings, potential cause attributed to component failure and 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 complaint condition.As part of depuy synthes 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 # 03.503.479, synthes lot # u399520.Supplier lot # u399520.Release to warehouse date: 17 mar 2022.Expiration date; na.Supplier: (b)(4).No ncr's generated during production.Device history batch: null.Device history review: 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 medwatch, a follow-up medwatch 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 to depuy synthes for evaluation.Visual inspection of the returned device found to be broken from the tip.The broken fragment was not returned for evaluation.The embedded device cannot be confirmed as no x-ray evidence was provided.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the drill bit ø1.5 f/matmand l125 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 depuy synthes 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 # 03.503.479, synthes lot # u399520, supplier lot # u399520, release to warehouse date: 17 mar 2022, expiration date; na, supplier: (b)(4).No ncr's generated during production.Device history review: 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 medwatch, a follow-up medwatch 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: b5, d9.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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received: a.Could you please confirm that there have been no health consequences for the patient and that no medical intervention has been required to date? - the surgeon consulted that there is no adverse effect as of now.B.May i seek your help to consult the consulting surgeon to advise on the potential clinical impact of leaving the 2.5 cm broken drill bit fragment in the patient¿s mandible? - the surgeon had mentioned that it shouldn¿t cause any issue.

• Brand Name: MATRIXMANDIBLE 1.5MM DRILL BIT MQC/125MM F/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: 24665314
• Report Number: 8030965-2026-02745
• Device Sequence Number: 9244024
• Product Code: DZI
• UDI-Device Identifier: 07611819975279
• UDI-Public: (01)07611819975279(10)U399520
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Physician
• 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: 03.503.479
• Device Lot Number: U399520
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 04/17/2026; 05/08/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 03/26/2026; 04/20/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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