MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QUIC

Catalog Number	03.010.061S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2026
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.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.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
It was reported that on (b)(6) 2026, the patient underwent an unknown surgery with the drill bit.When the surgeon was trying to lock the distal stent, he pressed the device too hard, causing interference with the nail.The surgeon used a hammer to knock the device through the nail hole.After connecting the drill to the power tool and starting drilling, the tip of drill bit broke.The drill tip remained inside the body, so it was excavated from the proximal cortical bone and removed.After that, the surgeon drilled freehand and inserted the locking screw.The surgery was completed successfully within 30mins of delay.The surgeon commented that the cortical bone was thick, so it seems that unusual stress was generated in the drill bit, causing it to break.No further information is available.
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 (expiration, lot).Corrected: d4 (primary udi #).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: h4.Corrected: g1.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable device history lot.Part:03.010.061s.Lot:407l984.Manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date: 08 jul 2025.Expiration date: 01 jul 2035.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device.Product code: 03.010.061-15.Lot number: 59490p3.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 12 jun 2025.Manufacturing site: jabil bettlach.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QUIC
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24189124
• Report Number: 8030965-2026-00929
• Device Sequence Number: 18145131
• Product Code: HTW
• UDI-Device Identifier: 10886982067340
• UDI-Public: (01)10886982067340(10)407L984
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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

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: 03.010.061S
• Device Lot Number: 407L984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 02/20/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 01/29/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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