MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 3.8 DIMTR DR BIT 25MM; DRILLS

Catalog Number	227456000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that the patient underwent a total hip arthroplasty (tha) for right acetabular aplasia using the drill.During the procedure the drill broke when the surgeon attempted to drill after the cup was placed.The surgery was completed without delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, it was reported that on (b)(6) 2025, the patient underwent the tha for right acetabular aplasia with the drill in the question.During the surgery, the drill was broken when the surgeon tried to drill after the cup placed.The surgery was completed without any surgical delay.No further information is available.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed quickset 3.8 dimtr dr bit 25mm has broken drill in two pieces.The fragment was returned for evaluation.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces, such as: heavy usage and multiple uses under extreme eccentric loading resulting in premature bending or failure of the drill bit.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the quickset 3.8 dimtr dr bit 25mm would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported 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 lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: QUICKSET 3.8 DIMTR DR BIT 25MM
• 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: 23840478
• Report Number: 1818910-2025-22172
• Device Sequence Number: 9527177
• Product Code: HTW
• UDI-Device Identifier: 10603295109310
• UDI-Public: (01)10603295109310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2025

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: 227456000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/17/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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