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

Model Number 72201519

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7787277
• MDR Text Key: 117257043
• Report Number: 1219602-2018-01075
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621641
• UDI-Public: (01)03596010621641(17)191114(10)50631209
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1