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

Catalog Number 7205326

Device Problem Temperature Problem (3022)

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

Event Date 11/13/2017

Event Type  malfunction  

Event Description

It was reported that when using the device, the shaver hand piece was getting very hot.No patient injuries were reported.

Manufacturer Narrative

Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.No further actions pursued at this time.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: ACROMIONIZER,4.0 EP-1,DSPL BL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7032692
• MDR Text Key: 92739674
• Report Number: 1219602-2017-01416
• 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: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1