MAUDE Adverse Event Report: DEPUY SPINE INC NAVIGATION ENABLED INSTRUMENTS DUAL LEAD AWL TIP TAP 5MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 301019022

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

It was reported that on (b)(6) 2023, during intra-op while using the 5.0mm verse nablock tap, surgeon was having difficulties advancing the 5.0mm tap while under the normal force of advancement.Approximately 30mm of the tap was into the pedicle of l5 (right) the distal end of the tap snapped off leaving the threaded part of the tap in the patient's pedicle.The tap broke at the transition point of the treads and the shaft of the tap.Surgeon decided that no harm would come from leaving the broken part of the instrument.Subsequently, pedicle screws were placed at l4 and s1 and skipping l5 on the right side.The procedure was completed successfully.There was no surgical delay.Distal tip of tap (approx.30mm) was left in the patient, unable to remove without additional intervention.No further information is available.This report is for a navigation enabled instruments dual lead awl tip tap 5mm.This is report 1 of 1 for (b)(4).

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.H3, h4, h6: a review of the receiving inspection (ri) for 5mm nav dual lead awl tip tap was conducted identifying that lot number: ng103033 was released in one batch.Batch 1: lot qty of (b)(4) units were released on 27 may 2021 with no discrepancies.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.The photo investigation revealed that the threaded tip of the 5mm nav dual lead awl tip tap was found broken, the broken fragments is not visible on photos.The investigation was able to confirm the reported event.No other problem identified.The device, component or fragment remains in patient issues could be not confirmed since x-ray evidence was not provided.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed for 5mm nav dual lead awl tip tap [301019022/ng103033].There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.

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.H10 additional narrative: h3, h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual investigation of the returned device found that the 5mm nav dual lead awl tip tap was found broken from the tip, the broken fragment was not returned for evaluation.Without an x-ray we cannot confirm that a fragment has remained inside the patient.No other issues were observed.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 for the 5mm nav dual lead awl tip tap was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the 5mm nav dual lead awl tip tap would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed.Dwg 103583834 rev.B current and manufactured.Dimensional inspection: n/a.H4, h6 a review of the receiving inspection (ri) for 5mm nav dual lead awl tip tap was conducted identifying that lot number ng103033 was released in one batch.Batch 1: lot units were released on 27 may 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.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.

• Brand Name: NAVIGATION ENABLED INSTRUMENTS DUAL LEAD AWL TIP TAP 5MM
• Type of Device: 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: 17642273
• MDR Text Key: 322179173
• Report Number: 1526439-2023-01548
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034561431
• UDI-Public: (01)10705034561431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 301019022
• Device Lot Number: NG103033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 08/30/2023; 09/18/2023
• Supplement Dates FDA Received: 09/14/2023; 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: PEDICLE.
• Patient Age: 55 YR
• Patient Sex: Female