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.

Manufacturer Narrative

H10, h3,h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No product identification information was provided and thus a product history review and complaint history review could not be conducted.

• 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
• MDR Report Key: 10694819
• MDR Text Key: 211876737
• Report Number: 1219602-2020-01608
• Device Sequence Number: 1
• Product Code: HAB
• 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: 03/27/2021

1 Device was Involved in the Event

1 Patient was 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
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1