MAUDE Adverse Event Report: DEPUY SPINE INC AWL TIP TAP 4.35 NAV; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	279702401N
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.H11 additional narrative:.Added: h6 health effect - impact code h3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the tip of the awl tip tap 4.35 nav was broken.The fracture surface was examined, and no damage related to material issues was observed.The broken surface suggest that the fracture was caused in one single event were the device was exposed to unintended forces causing a random failure of a component.The broken fragments were not returned.No post operative x-ray were provided, therefore the embedded allegation cannot be confirmed.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the awl tip tap 4.35 nav 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 = > a review of the receiving inspection (ri) for awl tip tap 4.35 nav was conducted identifying that lot number ng143640 released in one batch.¿ batch1: lot qty of (b)(4) units were released jul 9, 2024, with no discrepancies.Supplier: ng instruments 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.Device history review = > 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9, h4.Corrected: h5.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.
Event or Problem Description
It was reported that patient underwent spinal fusion on (b)(6) 2024.The resident was using the tap to tap the pedicle.When they went to remove the tap, it broke off inside the bone.The doctor then tried to retrieve the piece but was unable to do so.After some deliberation, surgeon decided to leave it in.There was a surgical delay of twenty-five minutes.The procedure was completed successfully.There was no clinical outcome experienced by the patient.

• Brand Name: AWL TIP TAP 4.35 NAV
• 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: 21124466
• Report Number: 1526439-2025-00048
• Device Sequence Number: 7462965
• Product Code: OLO
• UDI-Device Identifier: 10705034531694
• UDI-Public: (01)10705034531694(10)NG143640
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140927
• 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,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: 279702401N
• Device Lot Number: NG143640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 01/29/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/23/2025; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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