MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS ARRAY SET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	4515-70-001
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Problem reported: rss reports that the surgeon had to bail on a case due to a bumped array and array movement caused by the array clamp wing nut being loose and not securing the array.The surgeon is requesting the array clamp and the pin inserter be replaced as he believes both devices impacted the array movement.The reporter was not on site and received this information from the sales assoc.When was the issue observed? during surgery.What step were they on when this issue occurred? unknown.What steps did the caller or user perform after encountering this issue? bailed to manual instrumentation.Troubleshooting: patient involvement? yes.Were there reports of injuries, medical intervention or prolonged hospitalization? yes or no.Are patient treatments delayed or cancelled? slight delay in bailing to manual, no cancellations.Next day of surgery: (b)(6) 2022.All information has been disclosed.No further information was provided.If complaint is related to disposable/reuseables: disposable/reuseables: details have been emailed to the (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary : the device associated with this complaint was not received for examination.No photographs were provided for investigation.Based on all available information the investigation cannot confirm the reported allegation.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system could not be performed because the required lot code was not provided.

• Brand Name: VELYS ARRAY SET
• Common Device Name: 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: 14433879
• Report Number: 1818910-2022-09051
• Device Sequence Number: 5897999
• Product Code: OLO
• UDI-Device Identifier: 10603295519072
• UDI-Public: 10603295519072
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4515-70-001
• Device Catalogue Number: 451570001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELYS ARRAY CLAMP
• Patient Sex: Unknown