MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP

Catalog Number	03.010.101
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, the patient underwent an orif for right side femoral shaft fracture with the power tool.A short-sized rfna was originally inserted, so after removal of the nail, a 340mm one was reinserted.The operation proceeded smoothly from inserting the nail to stopping the distal locking.The radiolucent drive was used for the proximal locking stage.A drill hole was created using an intramedullary nail drill, and the radiolucent drive was used.The position was incorrect the first time, so the position was corrected and the drill was drilled again.When drilling again, the rotation was reversed, and the drill attached to the radiolucent drive became stuck.Using the radiolucent drive was discontinued, and the technique was changed to freehand, using the 4.2mm-145mm drill included in the implant set.After switching to freehand, the surgery was completed successfully within 30mins of delay.No further information is available.(b)(4) is related to (b)(4), which reports on a pts product.(b)(4) reports on syn product.
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: added: d9.Corrected: h4.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.
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 that the assembly area of the drill bit ø4.2 calibr l145 3flute w/coup was worn out.Additionally the cutting blades are stripped.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not able to be performed due to the mating device was not returned for evaluation.However, the customer¿s allegation can be substantiated, as the observed damage is completely related to the reported malfunction.The overall complaint was confirmed as the observed condition of the drill bit ø4.2 calibr l145 3flute w/coup 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# 03.010.101, synthes lot# u416548, supplier lot# u416548, release to warehouse date: 18.Nov.2022.Supplier: (b)(4).No ncrs were 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.

• Brand Name: DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP
• Common Device Name: DRILL BIT
• 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: 24453996
• Report Number: 8030965-2026-01939
• Device Sequence Number: 10148496
• Product Code: HTW
• UDI-Device Identifier: 10886982067685
• UDI-Public: (01)10886982067685(10)U416548
• 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
• Initial Reporter Occupation: Physician
• 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: 03.010.101
• Device Lot Number: U416548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 03/20/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/16/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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