MAUDE Adverse Event Report: DEPUY SPINE INC NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SHAFT T20 5.5; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 3010-19-003

Device Problem Break (1069)

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

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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) 2021 during an unknown procedure, the tip of the 5.5 nav screwdriver broke as the surgeon was implanting a pedicle screw.The broken tip was removed from the patient immediately.There was a brief delay in order to retrieve a new sterile screwdriver.The surgery was successfully completed.There were no patient consequences.This report is for one (1) navigation enabled instruments expedium driver - shaft t20 5.5.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the 5.5 nav driver - shaft t20 (p/n: 301019003, lot number: mi102001) was received at us cq.Visual inspection of the complaint device showed the distal tip of the device was broken, and broken fragments were not returned with complaint device.No other issues were observed with the complaint device.Dimensional inspection: feature: shaft diameter close to distal tip was measured per relevant drawing.Result: conforming document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device was received distal tip broken.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.A review of the receiving inspection (ri) for 5.5 nav driver - shaft t20 was conducted identifying that lot number mi102001 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 15 jun 2021 with no discrepancies.Nr was generated during final inspection it was noted the product did not meet the tp dia.0.4 a criterion.The non-conformance was invalidated, the parts were re-inspected using a corrected inspection method.The final determination was made that all parts were conforming.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 EXPEDIUM DRIVER - SHAFT T20 5.5
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12923643
• MDR Text Key: 281663738
• Report Number: 1526439-2021-02497
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034561387
• UDI-Public: 10705034561387
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3010-19-003
• Device Catalogue Number: 301019003
• Device Lot Number: MI102001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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