MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED F/R,BL,4.5MM,SERIES 3000 /6; SAW, POWERED, AND ACCESSORIES

Catalog Number	7206011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shavings peeling off right at the start of the case before any resection is even started.No patient injuries were reported.
Additional Manufacturer Narrative
Additional information.Three boxes, 18 unused 4.5mm full radius blades were returned for evaluation.Visually, the parts exhibited some signs of tarnish on the inner edgeform.There was no plating issues noted on the inner blade when reviewed under magnification.Functional assessment of the blades confirmed the inner blades rotated freely within the outer blades in the unloaded condition.Silver plating is a smith+nephew process used at the time of manufacture of these blades to improve lubricity and allow for friction free contact between the stainless steel inner and outer blades.The appearance of the "tarnish" and discoloration does not have any adverse effect on the performance of the device, procedure or patient.The tarnishing discoloration is a cosmetic issue only.Without the return of the devices that exhibited the reported shedding this investigation could not identify any evidence of product contribution to the reported complaint.Reportedly during the shoulder procedure shavings from the bone cutter peeled off right at the start of the case before any resection started.The shavings were removed using a grasper.The procedure was completed with the same device.No patient injuries are being reported.

• Brand Name: BOXED F/R,BL,4.5MM,SERIES 3000 /6
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8248806
• Report Number: 1219602-2019-00078
• Device Sequence Number: 1946918
• Product Code: HAB
• UDI-Device Identifier: 03596010440242
• UDI-Public: 03596010440242
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 02/12/2021
• Device Catalogue Number: 7206011
• Device Lot Number: 50752633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1