MAUDE Adverse Event Report: DEPUY SPINE INC NAVIGATION ENABLED INSTRUMENTS DUAL LEAD CANNULATED TAP 4.35MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	301019014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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.H3, h6 investigation summary: the product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation of " 301019014, 4.35mm nav dual lead can tap" revealed that the tip of the device has broken.The observed condition of the device was consistent with a random 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 4.35mm nav dual lead can tap would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to component failure 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 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 review (dhr): a review of the receiving inspection (ri) for 4.35mm nav dual lead can tap, was conducted identifying that lot number ng102994 was released in one batch.Batch1: lot qty of (b)(4) were released on apr 7, 2021, with no discrepancies.Supplier: (b)(4).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.
Event or Problem Description
It was reported that on an unknown date, the resident snapped the tip of the navigated tap off in the pedicle.There were no patient consequences.

• Brand Name: NAVIGATION ENABLED INSTRUMENTS DUAL LEAD CANNULATED TAP 4.35MM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21686271
• Report Number: 1526439-2025-00409
• Device Sequence Number: 8668140
• Product Code: OLO
• UDI-Device Identifier: 10705034561325
• UDI-Public: (01)10705034561325(10)NG102994
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K200791
• 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

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: 301019014
• Device Lot Number: NG102994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2021
• 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