MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATT FB TIB DRILL BUSHING POR; KNEE INSTRUMENT : DRILL GUIDES

Catalog Number	254511455
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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.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 reamer got stuck in tower.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- according to the information received, it was reported that reamer got stuck in tower.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device does not found signs of jammed at the att fb tib drill bushing por.However, the device was slightly deformed at the proximal section of the slide assembly where it slides the reamer.The observed damage can be mostly traced to an unintended use error by improper technique, misuse, or excessive force applied in an off-axis position, leading to the observed damage.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test was performed and revealed that the att fb center tib drill por could not be fully assembled in att fb tib drill bushing por.The inability to assemble was attributed to the condition of the tip and orifice.The overall complaint was confirmed as the observed condition of the att fb tib drill bushing por would have contributed to the complained issue.Based on the investigation findings, 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 j&j 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 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.H11 additional narrative: added: d9.Corrected: h3.

• Brand Name: ATT FB TIB DRILL BUSHING POR
• Common Device Name: KNEE INSTRUMENT : DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22742820
• Report Number: 1818910-2025-13870
• Device Sequence Number: 7534024
• Product Code: FZX
• UDI-Device Identifier: 10603295499350
• UDI-Public: (01)10603295499350(10)SO2063344
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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

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: 254511455
• Device Lot Number: SO2063344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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