MAUDE Adverse Event Report: DEPUY IRELAND UC VELYS ARRAY CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-107

Device Problems Mechanical Problem (1384); Premature Separation (4045)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

This is report 4 of 5 for the same event.It was reported that during a surgical procedure, it was observed the femoral cuts were off while the satellite station device was in use.Following the surgery, it was reported that the clinician pulled on the femoral arrays and observed that the array devices detached from the array clamps without pressing the button release on the array clamp devices.It was reported that there were a total of four array clamps that released the array without pressing the button.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization and the surgery was completed successfully.All available information has been disclosed.Multiple attempts have been made to obtain additional information.No additional information has been received.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi:(b)(4).Concomitant medical devices and therapy dates, array clamp devices and satellite station device, (b)(6) 2022.

Manufacturer Narrative

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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi:(b)(4).Concomitant medical devices and therapy dates, array clamp devices and satellite station device, (b)(6) 2022.

Event Description

This is report 4 of 5 for the same event.It was reported that during a surgical procedure, it was observed the femoral cuts were off while the satellite station device was in use.Following the surgery, it was reported that the clinician pulled on the femoral arrays and observed that the array devices detached from the array clamps without pressing the button release on the array clamp devices.It was reported that there were a total of four array clamps that released the array without pressing the button.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization and the surgery was completed successfully.All available information has been disclosed.Multiple attempts have been made to obtain additional information.No additional information has been received.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.Investigation summary: the returned device was evaluated to ensure functional fit.Fit check between the returned device was found to be a secure fit with the femoral array.Per surgical technique guide, correct assembly and disassembly of the femoral array (bone array) and array clamp is depressing the push button feature either to insert or to remove the femoral array respectively.It is unclear from the reported information, that femoral array was appropriately assembled and disassembled to the array clamp assembly, per the surgical technique instructions, prior and after resections.No component damage was observe,d on the array clamp assembly.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.Depuy considers, the investigation closed at this time.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude, that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: VELYS ARRAY CLAMP
• 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: 13621293
• MDR Text Key: 286275604
• Report Number: 1818910-2022-03768
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519379
• UDI-Public: 10603295519379
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-107
• Device Catalogue Number: 451570107
• Device Lot Number: J43054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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