MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HPUNI DISTAL FEM CUT BLK 1; INSTRUMENT, CUTTING, ORTHOPEDIC

Catalog Number	252510100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2025
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the pin stuck in cutting block broke off when trying to remove.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported that the pin stuck in cutting block broke off when trying to remove did not delay surgery.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the hpuni distal fem cut blk 1 has a broken and stripped unk fixation pin attached in one of the insertion holes, the fixation pin was unable to disengage after multiples attempts, the reported jammed condition was confirmed.The observed condition is consistent with the unintended overnighting of the the unknown fixation when assembling it to the distal fem cut blk, properly handling and attention to the approved use of the device diminishes the risk of failure.The intuition instruments surgical technique can be reviewed for more information on the alignment and use of the device.A functional test was unable to be performed due to the post-manufacturing damage.However the jammed condition was confirmed due to the broken fixation pin attached to the distal fem cut blk.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the distal fem cut blk 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 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: corrected: h3.

• Brand Name: HPUNI DISTAL FEM CUT BLK 1
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21576947
• Report Number: 1818910-2025-03758
• Device Sequence Number: 8225473
• Product Code: HTZ
• UDI-Device Identifier: 10603295544487
• UDI-Public: (01)10603295544487(10)SO2060139
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 252510100
• Device Lot Number: SO2060139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: Unknown