MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/QUIC

Catalog Number	03.010.060
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2025
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.Additional narrative: investigation summary the product was not returned to medtech orthopaedics , however photos were provided for review.The photo investigation revealed that 03.010.060, drill bit ø3.2 calibr l340 3flute f/quichas been 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 photographs attached were reviewed, however the provided evidence was not sufficient to confirm the reported event of inability to embedded device.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 confirmed as the observed condition of the drill bit ø3.2 calibr l340 3flute f/quic would contribute to the complained device issue.Based on the investigation findings, the drill bit ø3.2 calibr l340 3flute f/quic has broken because of cause trace 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 medtech orthopedics 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 a manufacturing record evaluation was performed for the finished device product code: 03.010.060 lot number:8454p11 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 19 dec 2023 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.
Event or Problem Description
It was reported during the procedure, while performing the drilling with drill bit, the tip broke off, leaving a small fragment inside the patient's bone.Since it could not be removed, the doctor decided to leave this fragment in place due to the difficulty of extraction and because there would be no problem leaving it in the bone.The remaining portion of the aforementioned drill bit was then removed, and another drill bit of the same type, also available in the kit, was used.The surgery was successfully completed without any delays.Patient was stable.

• Brand Name: DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/QUIC
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23682675
• Report Number: 8030965-2025-11948
• Device Sequence Number: 21261472
• Product Code: HTW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 03.010.060
• Device Lot Number: 8454P11
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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: Male