MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 INTUITION; BIT, DRILL

Catalog Number	252550002
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
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.Additional narrative: h3, h6: product investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found rounding on its cutter surface, the cutter tip deformed, little nicks on the hudson adaptor head and signs of usage on its overall surface.No other cosmetic anomaly was identified on the evidence provided.The observed condition can be traced to an off-axis assembly with its mating component; excessive force during trialing; or by actuating the device before it was fully seated.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.However, based on the damage observed on the device, it is reasonable to consider a difficulty in the assemblance with its mating devices; as well as to impede the device to "run"/function as intended.The overall complaint was confirmed as the observed condition of the hpuni femoral peg drill would have contributed to the complained device issue.Based on the investigation findings, 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 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.H3, h4, h6: device history record (dhr) review conducted: quantity manufactured: (b)(4) pieces.Date of manufacture: 02/28/2025.Any anomalies or deviations identified in dhr: no anomalies were found for this order a manufacturing record evaluation was performed for the finished device ng150846 lot number, and no non-conformances nor manufacturing irregularities 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
It was reported that the drill does not run smoothly.It is wobbly.There was no patient harm and no surgical delay reported.

• Brand Name: INTUITION
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25666029
• Report Number: 1818910-2026-11160
• Device Sequence Number: 17583744
• Product Code: HTW
• UDI-Device Identifier: 10603295544678
• UDI-Public: (01)10603295544678(10)NG150846
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 252550002
• Device Lot Number: NG150846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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
• Patient Sex: Unknown