MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 3.8 DIMTR DR BLT 40MM; DRILLS

Catalog Number	227457000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 the drill bit broke during drilling.The broken bit was removed and another drill bit was used instead.The procedure was completed successfully with no delay or impact to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received that "during the procedure, while performing the drilling, the drill bit broke.This issue was resolved by removing the broken bit and providing the surgeon with a replacement bit of the same type, which was also included in the kit.The surgical instrument technician was immediately informed of this incident.The surgeon was not bothered by this issue, the surgery was completed successfully, the patient was not affected, and there were no changes to the surgical schedule.A report was submitted to document the incident.The broken drill bit was left with the equipment for easy identification and replacement when the devices are returned to j&j.The product was not returned to medtech orthopedics; however, photos were provided for review.The photo investigation revealed that "227457000, quickset 3.8 dimtr dr blt 40mm " broken intraoperatively while drilling.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces such as drilling in an misaligned position, extreme eccentric loading resulting in premature bending or failure of the drill bit, heavy usage, prying motion.Properly handling and attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the "227457000, quickset 3.8 dimtr dr blt 40mm " would contribute to the complained device issue.Based on the investigation findings, the ¿dimtr dr blt¿ has ¿broken¿ 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: e1 initial reporter.

• Brand Name: QUICKSET 3.8 DIMTR DR BLT 40MM
• Common Device Name: DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23584194
• Report Number: 1818910-2025-20248
• Device Sequence Number: 9378123
• Product Code: HTW
• UDI-Device Identifier: 10603295109327
• UDI-Public: (01)10603295109327(10)NG62575
• 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,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: 227457000
• Device Lot Number: NG62575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2025
• Supplement Date Received by Manufacturer: 02/01/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2021
• 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: Unknown