MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS SAW INTERFACE RIGHT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-106

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: the physical device was returned, the fse was able to confirm the issue as per wo: ¿fse was able to replicate the reported issue, the sasi was loose.This issue is within scope of an ongoing investigation in the depuy synthes quality management system (qms).Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Problem reported: customer reported that they are having terrible issues with the saw cutting out.When was the issue observed: during surgery.Troubleshooting: during the distal cut the surgeon would pull the trigger and only get short burst of power.Site has quarantined the saw hand piece and will have both sets available for testing when the fse arrives.Fse support requested patient involvement? yes.Were there reports of injuries, medical intervention or prolonged hospitalization? no.Are patient treatments delayed or cancelled? no.Next day of surgery: next wednesday: unknown.Time of day: morning.All information has been disclosed.No further information was provided.

• Brand Name: VELYS SAW INTERFACE RIGHT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16572766
• MDR Text Key: 312225462
• Report Number: 1818910-2023-06185
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519478
• UDI-Public: 10603295519478
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4515-70-106
• Device Catalogue Number: 451570106
• Device Lot Number: J46972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1