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

Model Number 7205325

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  Injury  

Event Description

It was reported that during the procedure, the blade was showing metal debris in the joint when it is used and rubbing on the inside shaft of the blade; the procedure was successfully completed with less than 30 minutes delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already captured under (1219602-2020-01267) therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: ABRADER 5.5 EP-1 DSPL BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10445538
• MDR Text Key: 204170731
• Report Number: 1219602-2020-01300
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251534
• UDI-Public: 03596010251534
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205325
• Device Catalogue Number: 7205325
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention