MAUDE Adverse Event Report: DEPUY IRELAND VELYS SAW INTERFACE LEFT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-105

Device Problems Material Fragmentation (1261); Connection Problem (2900)

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

Event Date 07/06/2022

Event Type  malfunction  

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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation.Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.Visual inspection of both returned left sasis confirmed the honeycomb connection feature was chipped and cracked.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Visual inspection of both returned left sasis confirmed the honeycomb electrical connection feature of the saw interface port was chipped and cracked.The overall condition of devices show wear and burnishing consistent with being subjected to multiple uses and cleaning/sterilization cycles over the useful life of the device.The damage to the honeycomb connection is consistent with not using the cleaning cap to protect the saw interface port during cleaning and transportation.Per the instruction for use, under the section for reusable instruments, it is indicated, "the port of each saw interface must be plugged with the saw interface cleaning cap (p/n 451570226) before placing them in a hospital transportation case and cleaning to avoid debris accumulation and other damage within the electrical connection.¿ as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the sasi is consistent with the reported event.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, the potential cause of the observed electrical port damage is traced to maintenance and 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.Udi:(b)(4).

Event Description

This is report 2 of 2 for the same event.It was reported that the robotic assisted saw interface devices (x2) had cracks in the honeycomb of the connector.During an in-house engineering evaluation, it was determined that the device electrical connection feature of the saw interface port was chipped and cracked.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any 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.

• Brand Name: VELYS SAW INTERFACE LEFT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15379401
• MDR Text Key: 302700257
• Report Number: 1818910-2022-17396
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519461
• UDI-Public: 10603295519461
• 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
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-105
• Device Catalogue Number: 451570105
• Device Lot Number: J44924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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