MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø0.8 L40/16 2FLUTE

Catalog Number	316.385
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
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.Additional narrative: the product was not returned to medtech orthopaedics; however photos were provided for review.The photo investigation revealed that '(316.385 ,drill bit ø0.8 l40/16 2flute) had broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.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 ø0.8 l40/16 2flute) would contribute to the complained device issue.Based on the investigation findings, caused 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 part# 316.385 lot # f-26931 manufacturing site: werk selzach logistik manufacturing date: 13.April.2019 expiration date: n/a supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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
During the procedure, at the time of performing the osteosynthesis on the right hand phalanx and when starting the first perforation with a # 0.8 drill bit to place a 0.1 screw, the drill bit broke in half at that moment.It is not known exactly where the other part of the drill bit fell, which is why it was verified with x-rays that it had not remained inside the patient's bone.The procedure continued with another drill bit with the same characteristics that also came with the equipment and the surgery was successfully completed without complications, without discomfort for the specialist, without affectations to the patient and without alterations in surgical times.

• Brand Name: DRILL BIT Ø0.8 L40/16 2FLUTE
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21305751
• Report Number: 8030965-2025-01283
• Device Sequence Number: 8848629
• Product Code: HTW
• UDI-Device Identifier: 07611819081048
• UDI-Public: (01)07611819081048(10)F-26931
• 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: 316.385
• Device Lot Number: F-26931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2019
• 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