MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE REV AUGMENT WOBBLE BIT; SCREWDRIVERS

Catalog Number	254600411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 prior to an arthroplasty surgical procedure, the tip of the wobble bit screw driver fell onto the floor and the head broke and was unable to be used.This happened before the patient was brought into the or room.Another screwdriver was retrieved from an additional set and the case proceeded smoothly without issue.If other, describe total knee revision, did the event occur during sterile processing? no, did the event occur during field inspection? no, did the event occur during internal service activities such as calibration? no, patient status/ outcome / consequences no patient involvement, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study no.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received that "the tip of the wobble bit screwdriver fell onto the floor and the head broke and was unable to be used.This happened before the patient was brought into the or room.Another screwdriver was retrieved from an additional set and the case proceeded smoothly without issue.¿.This complaint involves one (1) device.The product was not returned to depuy synthes; however, photos were provided for review.The photo investigation revealed that ¿254600411, attune rev augment wobble bit¿ has broken.The observed condition of the device was consistent with a 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 attune rev augment wobble bit would contribute to the complained device issue.Based on the investigation findings, attune rev augment wobble bit was broken because of unintended user error, 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 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: the device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ATTUNE REV AUGMENT WOBBLE BIT
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24067588
• Report Number: 1818910-2026-00769
• Device Sequence Number: 10267312
• Product Code: HWR
• UDI-Device Identifier: 10603295440376
• UDI-Public: (01)10603295440376
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 254600411
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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