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	11/27/2025
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that drill bit ø2 w/double marking l140/115 3, drill bit ø2/1.15 cann l150/48 3flute f/, and k-wire ø1 l150 sst were involved in an intraoperative event.During the procedure, shortages of a 2.0 drill bit and a 1.0 k-needle were identified upon opening the equipment.Later, the 2.0 drill bit broke, leaving its tip embedded in the patient's bone.The fragment could not be removed and was intentionally left in place, as it was determined there would be no adverse consequence.The remaining portion of the drill bit was removed, and a replacement drill bit was used to complete the surgery without delay or discomfort to the specialist.
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 (concomitant).H3, h6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that '323.062, drill bit ø2 w/double marking l140/115 3¿ had broken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The allegation of embedded device can not be confirmed as no patient x-rays were provided to evaluate the condition.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 ø2 w/double marking l140/115 3 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed 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 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 review (dhr): a dhr evaluation was performed for the finished device.Product code: 323.062.Lot number: 76971p5.It was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 07-august-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: 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: 23829243
• Report Number: 8030965-2025-12695
• Device Sequence Number: 13083372
• Product Code: KTW
• 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,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: 323.062
• Device Lot Number: 76971P5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 09/14/2026; 09/23/2026; 09/24/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/31/2025; 09/16/2026; 09/24/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE F/; K-WIRE Ø1 L150 SST
• Patient Sex: Male