MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE STONECUTTER BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200728
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that after connecting the burr on the handpiece, the burr stopped turning and the handpiece sets to alarm state.Removing the burr, plastics had been damaged.The surgeon changed the handpiece and the incident repeated again.Then the surgeon used another burr (other product reference with bigger diameter and it was ok.) no plastics pieces were left into the patient.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
The reported stonecutter burrs intended for use in treatment, have not been returned for evaluation, however a photograph was supplied, visual assessment of the photograph confirmed the polycarbonate components the sluff chamber and adapter body are melted and fused together.The cause of the melting/seizing is due to improper fluid flow during operation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
One 4.0 mm elite stonecutter burr was returned for evaluation.Visual assessment of the burr found that the polycarbonate components the sluff chamber and adapter body are fused together showing evidence of being operated with inadequate irrigation.The cause of the melting/seizing is due to improper fluid flow during use.Per the device instructions for use under warnings ¿periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running¿.No root cause related to the manufacture of the device can be established¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DYONICS 4.0MM ELITE STONECUTTER BURR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8709609
• Report Number: 1219602-2019-00721
• Device Sequence Number: 2212286
• Product Code: HAB
• UDI-Device Identifier: 03596010578068
• UDI-Public: 03596010578068
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2023
• Device Catalogue Number: 72200728
• Device Lot Number: 50774845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 07/15/2019; 08/13/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 06/18/2019; 07/16/2019; 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1