MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS SAW BLADE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 451570000

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.

Event Description

It was reported that the saw blade detached from saw hand piece while cutting femur, saw blade stayed embedded in the femur.Black liquid was noted around where the saw blade attaches to the saw hand piece.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 5.

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.

Event Description

Additional information was received and stated that there were no reports of any patient consequences.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, ¿saw blade detached from saw hand piece while cutting femur, saw blade stayed embedded in the femur.Black liquid was noted around where the saw blade attaches to the saw hand piece.¿ the product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence reveled a velys saw blade unassembled from the velys saw handpiece; however, no evidence of the device being embedded to patient was provided.In addition, a black substance was observed on the proximal section of the blade.The origin of the substance is unknown, but it is suspected to be related to the handpiece.It is worth mentioning, that photos of the product code and serial number of the handpiece were provided.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: VELYS SAW BLADE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18912725
• MDR Text Key: 337763177
• Report Number: 1818910-2024-05826
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519140
• UDI-Public: 10603295519140
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K202769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 451570000
• Device Lot Number: VE200024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 05/13/2024; 09/29/2015
• Supplement Dates FDA Received: 05/17/2024; 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention