MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN DISPOSABLE BLADE AND BURR SAW, POWERED, AND ACCESSORIES

Catalog Number UNKN04200200

Device Problem Break (1069)

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

Event Date 09/28/2020

Event Type  Malfunction  

Event Description

It was reported that, during a shoulder replacement, the attached blade melted/broke off in the handpiece. It is unknown how the procedure was completed. No significant delay or patient injury was reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: UNKN DISPOSABLE BLADE AND BURR
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10694822
• MDR Text Key: 211876269
• Report Number: 1219602-2020-01609
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/18/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/18/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNKN04200200
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial