MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER, 3.5, MAG-MINI, DISP. BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	72201519
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pieces of metal were flying off of them while being used in a case.The pieces felt off into the patient's anatomy, all the pieces were removed from the patient.Back-up device was available.As per customer response there was no harm to the patient.
Additional Manufacturer Narrative
One single 72201519 disposable 3.5mm mini magnetic abrader blade returned.These are sold as a box of six.This product is not intended to be or tested to be sold individually.The complaint stated: "it was reported that pieces of metal were flying off of them while being used in a case.The pieces felt off into the patient's anatomy, all the pieces were removed from the patient.Back-up device was available.As per customer response there was no harm to the patient." the blade is in relatively good condition with exception of small dings on the blade bulb edges and light circular scratches around the distal diameter of the inner shaft.Although light, the degradation of the surface could create light metallic debris.This is a small scale device which is not intended to have pressure applied.No root cause related to the manufacture of the device was established.Complaint history search revealed no other complaints for this production lot.

• Brand Name: ABRADER, 3.5, MAG-MINI, DISP. BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7787277
• Report Number: 1219602-2018-01075
• Device Sequence Number: 16465614
• Product Code: HAB
• UDI-Device Identifier: 03596010621641
• UDI-Public: (01)03596010621641(17)191114(10)50631209
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 11/14/2019
• Device Model Number: 72201519
• Device Catalogue Number: 72201519
• Device Lot Number: 50631209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1