MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM DRILL BIT/K-WIRE ATTCHMT FOR GLIDING HOLE/62MM; BIT, DRILL

Catalog Number	03.130.210
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2025
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.H11 additional narrative: h3, h6 investigation summary: the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that '03.130.210, drill bit ø1.5 l62/31 f/gliding hole' had broken.The investigation was not able to confirm the allegation of embedded device as no x-rays were provided to evaluate the condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 ø1.5 l62/31 f/gliding hole would contribute to the complained device issue.Based on the investigation findings, cause traced 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 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): part# 03.130.210.Lot # f-20576.Manufacturing site: werk selzach logistik.Manufacturing date: 28.Sep.2016.Expiration date: n/a.Supplier: sphinx werkzeuge ag.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.
Event or Problem Description
During the procedure, while drilling, the 1.1 drill bit broke, leaving the tip of this drill bit inside the patient's bone.An attempt was made, but it was not possible to remove this fragment of the drill bit that broke, and the doctor decided to leave the tip inside the bone and look for a new hole to drill with a new 1.1 drill bit that also came with the equipment, thus successfully completing the surgery.There was no surgical delay.

• Brand Name: 1.5MM DRILL BIT/K-WIRE ATTCHMT FOR GLIDING HOLE/62MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21755565
• Report Number: 8030965-2025-03078
• Device Sequence Number: 9701091
• Product Code: HTW
• UDI-Device Identifier: 07611819690615
• UDI-Public: (01)07611819690615(10)F-20576
• 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
• 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: 03.130.210
• Device Lot Number: F-20576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2016
• 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