MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR, 5.5MM,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205314
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the joint was being cleaned it was noticed that the blade was releasing metal particles, and these spread throughout the joint.The procedure was completed with the same device.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
One 5.5mm (b)(4) blade was returned for evaluation.Visual assessment of the device showed visible signs of material galling and debridement on the inner blade confirming the reported shedding.The outer blade is bent.The condition of the device indicates the blade was subjected to excessive side-loading during use.

• Brand Name: INCISOR, 5.5MM,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7339775
• Report Number: 1219602-2018-00336
• Device Sequence Number: 19180765
• Product Code: HAB
• UDI-Device Identifier: 03596010251428
• UDI-Public: (01)03596010251428(17)220420(10)50660058
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2018

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: 04/22/2022
• Device Model Number: 7205314
• Device Catalogue Number: 7205314
• Device Lot Number: 50660058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 04/02/2018; 05/08/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/11/2018; 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1