MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number 7205668

Device Problems Overheating of Device (1437); Vibration (1674); Noise, Audible (3273)

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

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign post code - (b)(6).

Event Description

It was reported that, during a shoulder arthroscopy, the blade heated up and vibrated with a strange noise.A back-up device was available to complete, without delay, the procedure.The patient did not experience any adverse consequence.

Event Description

It was reported that, during a shoulder arthroscopy, the motor drive unit heated up and vibrated with a strange noise.A back-up device was available to complete, without delay, the procedure.The patient did not experience any adverse consequence.

Manufacturer Narrative

The reported device 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.

Manufacturer Narrative

The initial incident report was submitted with incorrect manufacturing site information and registration number 1219602 (s+n mansfield).The correct manufacturing site information and registration number is 1643264(s+n oklahoma).Corrected data: d3 and g1 manufacturing site name, address and contact information.

• Brand Name: ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8643131
• MDR Text Key: 146231767
• Report Number: 1219602-2019-00604
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010293084
• UDI-Public: 03596010293084
• 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,Followup
• Report Date: 02/08/2020

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: 03/30/2023
• Device Model Number: 7205668
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 50724367
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/26/2019
• Supplement Dates Manufacturer Received: 07/04/2019; 07/18/2019; 02/08/2020
• Supplement Dates FDA Received: 07/01/2019; 07/19/2019; 02/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1