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

Model Number 4515-70-107

Device Problems Appropriate Term/Code Not Available (3191); Premature Separation (4045)

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

Event Date 10/14/2021

Event Type  malfunction  

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.The reporter was not able to provide the associated lot number for this event so the lot numbers provided were j43052 and j43054 and it is unknown which of the two devices is associated with the reported event.

Event Description

It was reported that during surgery that the array clamp device disassociated from the array.It was also reported that the array clamp appeared to have loosened.It was reported that there was a 40 minute surgical delay.It was reported that the user went to manual instrumentation following the event.There were no reports of 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

Product complaint (b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 appropriate term/code not available (a27) is used to capture undetermined allegation.

Event Description

Additional information received from the reporter stated "by broken, i mean that the instrument was no longer able to function normally during the case resulting in going to standard instrumentation.So, no it wasn¿t visually broken, more functionally.All sets were sent in as we had the array holders separated and instructed the spd staff to keep the array and holder separate from the rest and i would pick up once cleaned.They did not do this so all were sent in for your review.".

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.Investigation summary: the actual device was returned for evaluation.As the user was unable to determine, which device (lot j43054 or j43052) was involved in the event.All three returned devices were tested.The velys femur array, array clamp assembly was inspected.Assembly (fit check) with production equivalent velys femur array was performed and successful.It was observed, that the array clamp button snapped back to origin for both lots inspected.It was observed, that movement was possible if forced.However, the femur array remained assembled to array clamp.An additional inspection was performed, and indicated no signs of damage, or seized (galled) components.It was observed, that there was successful assembly and disassembly of the mating subassemblies.Therefore, the reported condition was not confirmed.As the reported condition was not confirmed, an assignable root cause was not determined.If information is obtained, that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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.

• 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: 12805026
• MDR Text Key: 280705480
• Report Number: 1818910-2021-24965
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2022

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: 4515-70-107
• Device Catalogue Number: 451570107
• Device Lot Number: J43052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 12/03/2021; 01/13/2022; 03/09/2022
• Supplement Dates FDA Received: 12/14/2021; 01/13/2022; 03/11/2022
• 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