MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

Catalog Number	323.062
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two drill bits of 2.0mm reference were broken intra-operatively; one of the parts of the drill bit remained in the patient, did not affect the patient or the surgical procedure was prolonged.
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 report, a follow-up report will be filed as appropriate.H11 additional manufacturer narrative: e1 initial reporter state: (b)(6).H3, h6: a manufacturing record evaluation was performed for the finished device product code: 323.062 lot number: 4507p71 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 24 feb 2023 manufacturing site: jabil bettlach.The product was not returned to medtech orthopedics; however, photos were provided for review.The photo investigation revealed that '323.062 drill bit ø2 w/double marking l140/115 3' has broken pieces at the tip.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.However for the reported event of embedded device, the provided evidence was not sufficient to confirm the reported event of embedded device as no x-rays are provided.Since the device was not returned, a dimensional inspection cannot be performed.Based on the investigation findings, the ¿drill bit ø2 w/double marking l140/115 3¿ has ¿broken (2+ pieces)¿ because of unintended force, 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.The overall complaint was confirmed as the observed condition of the drill bit ø2 w/double marking l140/115 3 would contribute to the complained device issue.

• Brand Name: 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22963314
• Report Number: 8030965-2025-08976
• Device Sequence Number: 15585770
• Product Code: KTW
• UDI-Device Identifier: 10886982190758
• UDI-Public: (01)10886982190758(10)4507P71
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 323.062
• Device Lot Number: 4507P71
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2023
• 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 Age: 29 YR
• Patient Sex: Unknown