MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER 2.9 MAG-MINI DISP. BLADE; SAW, POWERED, AND ACCESSORIES

Model Number 72201518

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2020

Event Type  Injury  

Event Description

It was reported that, during a wrist arthroscopic surgery using a "2.9mm abrader blade", metal pieces were found while removing the sclerotic bone.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that, during a wrist arthroscopic surgery using a "2.9mm abrader blade", metal pieces were found while removing the sclerotic bone.The metallic pieces were successfully removed from the patient.The pieces were removed using tweezers and suction.The procedure was completed using a back-up device.It is unknown if there was a delay.No other complications were reported.

Manufacturer Narrative

H10: b5: event description updated.

Manufacturer Narrative

Internal complaint reference (b)(4).

• Brand Name: ABRADER 2.9 MAG-MINI DISP. BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10558141
• MDR Text Key: 207689391
• Report Number: 1219602-2020-01436
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: 03596010621672
• 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,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: 72201518
• Device Catalogue Number: 72201518
• Device Lot Number: 50832090
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/20/2020
• Supplement Dates Manufacturer Received: 09/17/2020; 06/02/2021
• Supplement Dates FDA Received: 09/24/2020; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR