MAUDE Adverse Event Report: DEPUY SPINE INC 5MM DOUBLE-LEAD TAP; TAP, BONE

Catalog Number	299704050
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, 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.Additional narrative: investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the tip was slightly bent.No other problem identified.¿ the observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was not performed due to post manufacturing damage.¿ a functional evaluation was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the 5mm double-lead tap 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.Dimensional inspection: n/a device history a review of the receiving inspection (ri) for5mm double-lead tap was conducted identifying that lot number pu118679 released in one batch.¿ batch1: lot qty of (b)(4) units were released may 23, 2017 with no discrepancies.Supplier: paragon medical, inc.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 a 5mm tap shaft was found visibly bent on inspection by surgeon.No surgical delay.

• Brand Name: 5MM DOUBLE-LEAD TAP
• Common Device Name: TAP, BONE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 22168505
• Report Number: 1526439-2025-00728
• Device Sequence Number: 9254904
• Product Code: HWX
• UDI-Device Identifier: 10705034466972
• UDI-Public: (01)10705034466972(10)PU118679
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 299704050
• Device Lot Number: PU118679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2017
• 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