MAUDE Adverse Event Report: DEPUY IRELAND UC VELYS SAW HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-102

Device Problems Break (1069); Unintended System Motion (1430); Intermittent Loss of Power (4016)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported that prior to a procedure, it was observed that the saw handpiece device, while being used with a base station device and satellite station device stuttered back and forth without the saw trigger being pressed.It was reported that this occurred at the first cut (distal femur cut) before the trigger was pulled for any part of the procedure.It was reported that the oscillating behavior of the saw was very slow, operating at about 2 oscillations per sec and continued for 5-10 seconds.During that time, the surgeon held the saw still with one hand and tested the trigger forward with the other, which did not affect the behavior.As a troubleshooting measure, the surgeon again tried pulling the trigger rapidly.On the 3rd pull, the saw was fully engaged and ran at full power for a brief time.However, it stopped running briefly, and the surgeon repeated the troubleshooting step of rapidly pulling the trigger.The saw ran for a short time and stopped again.The surgeon repeated the rapid trigger pulling action, and the saw started running for a brief time and again stopped running.On the third iteration of this behavior, the saw started at full power and ran for the remainder of the case.However, it appeared to stop running very briefly throughout the case.There seemed to be no apparent reason for this behavior because the surgeon's saw technique gave no indication he was causing the issue, and the camera could easily see the saw.For example, the surgeon moved the saw with constant force in short intervals giving the saw time to cut bone effectively.The surgeon also moved the saw straight in and out, allowing it to use the maximum cutting surface and not allowing the blade's sides to be bound by an uncut surface.No delays to the case were reported due to the event.It was reported that all cuts were made successfully with good outcomes.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant medical devices and therapy dates, satellite station device and base station device, (b)(4) 2022.Udi :(b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant medical devices and therapy dates, satellite station device and base station device, (b)(4) 2022.Udi :(b)(4).

Event Description

It was reported that prior to a procedure, it was observed that the saw handpiece device, while being used with a base station device and satellite station device stuttered back and forth without the saw trigger being pressed.It was reported that this occurred at the first cut (distal femur cut) before the trigger was pulled for any part of the procedure.It was reported that the oscillating behavior of the saw was very slow, operating at about 2 oscillations per sec and continued for 5-10 seconds.During that time, the surgeon held the saw still with one hand and tested the trigger forward with the other, which did not affect the behavior.As a troubleshooting measure, the surgeon again tried pulling the trigger rapidly.On the 3rd pull, the saw was fully engaged and ran at full power for a brief time.However, it stopped running briefly, and the surgeon repeated the troubleshooting step of rapidly pulling the trigger.The saw ran for a short time and stopped again.The surgeon repeated the rapid trigger pulling action, and the saw started running for a brief time and again stopped running.On the third iteration of this behavior, the saw started at full power and ran for the remainder of the case.However, it appeared to stop running very briefly throughout the case.There seemed to be no apparent reason for this behavior because the surgeon's saw technique gave no indication he was causing the issue, and the camera could easily see the saw.For example, the surgeon moved the saw with constant force in short intervals giving the saw time to cut bone effectively.The surgeon also moved the saw straight in and out, allowing it to use the maximum cutting surface and not allowing the blade's sides to be bound by an uncut surface.No delays to the case were reported due to the event.It was reported that all cuts were made successfully with good outcomes.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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.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.The actual device was returned for evaluation.Upon investigation of the returned device it was determined that it was confirmed that the saw was running at a slow speed without the trigger being pulled.Data from the saw handpiece showed that the trigger was being lightly pressed which resulted in the sawblade moving back and forth at a low inconsistent speed was either due to the electronic control unit saw trigger, either an auto-calibration issue or sensitivity to external magnetic field.The device was functioning normally after the initial event for the remainder of the procedure.The assignable root cause was determined to be due to environmental conditions.Review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.

• Brand Name: VELYS SAW HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND UC; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthpaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 13562916
• MDR Text Key: 285964019
• Report Number: 1818910-2022-03063
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519430
• UDI-Public: 10603295519430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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 Model Number: 4515-70-102
• Device Catalogue Number: 451570102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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