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

Catalog Number	03.010.061
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent a femur osteosynthesis on (b)(6) 2024.When inserting the triple guide in the directional arm, it was observed that it entered with difficulty.In addition to the moment of drilling the distal block hole, it was observed that the bits had no edge, which caused discomfort in the specialist, because due to the difficulty presented during the procedure he had to release and place the triple guide in multiple times where in each of it the same sensation was perceived (it felt quite hard).The bit was changed and it is evident that although it manages to pass, this does it with a little difficulty; it was brocked then with a little strength to get the bits passed.The surgery was finished successfully without affecting the patient and without alterations in the surgical times.
Additional Manufacturer Narrative
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.
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: d10.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.H3, h4, h6: the product was not returned to medtech orthopaedics, however photos were provided for review.¿the photo investigation revealed that 03.010.061, drill bit ø4.2 calibr l340 3flute f/quic had no visible cosmetic defects.The evidence provided was not sufficient to confirm the reported event will not cut/dull.Functionality issues cannot be evaluated through a photo investigation.¿ since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the drill bit ø4.2 calibr l340 3flute f/quic would not contribute to the complained device issue.Based on the investigation findings, the potential cause cannot be established, 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 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 review = > a manufacturing record evaluation was performed for the finished device.Product code: 03.010.061.Lot number: 8594p28.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 02-feb-2024 manufacturing site: jabil bettlach.
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.H11 additional narrative: added: 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.
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, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the device found blunting/rounding of cutting edges.It is not unreasonable that the condition identified in visual analysis would contribute to a dull condition.Therefore, we are able to confirm dullness with damage observed, as this kind of evidence indicates repeated use of the device.The lifecycle requirements of the device are event related and depend on the use in clinical practice; 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 not performed due to post manufacturing damage.A functional evaluation was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the drill bit ø4.2 calibr l340 3flute f/quic 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 review (dhr): a manufacturing record evaluation was performed for the finished device.Product code: 03.010.061.Lot number: 8594p28.It was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 02-feb-2024.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: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20856923
• Report Number: 8030965-2024-14691
• Device Sequence Number: 20957778
• Product Code: HTW
• UDI-Device Identifier: 07611819760899
• UDI-Public: (01)07611819760899(10)8594P28
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• 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: 03.010.061
• Device Lot Number: 8594P28
• 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: 11/23/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 05/26/2025; 07/31/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/17/2024; 05/27/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QUIC; DRILLSL YELL
• Patient Sex: Unknown