MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203013

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

It was reported that during a knee procedure, a black residue/stain was left inside the patient after using the blades.The procedure was completed with the same device with no significant delay and no patient injury reported.

Manufacturer Narrative

Correction on initial reporter name and address and report source.Correct country is new zealand.

Manufacturer Narrative

The complaint stated: ¿a black residue/stain was left inside the patient after using the blades.¿ the inner edgeform blades were grasped between, rotated and wiped on paper.Two light but visible tracks of fine grey particulate remained on the paper.The used two had more noticeable particulate mixed with bio substance.The new blade left lighter, but visible shading.The product was all tested and performed as expected.There were no abnormalities noted.The sluff chamber, both blades and tips had no outstanding observations.The blade connected, ran in forward, reverse and oscillating.It switched between modes with no issue.There were no error messages indicated on the control panel.The complaint was assigned to engineering for further evaluation.Per engineering: the effects observed are consistent with the effects warned against in the instruction for use when the device instructions are not followed.Based the results of the investigation, no further action is warranted at this time.

• Brand Name: 4.5MM INCISOR PLUS PLATINUM BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8873622
• MDR Text Key: 153690645
• Report Number: 1219602-2019-00931
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2024
• Device Catalogue Number: 72203013
• Device Lot Number: 50787193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1