MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE

Catalog Number 72200873

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During a subacromial decompression, it was reported that the powermax hand piece and 4.5 incisor blade felt extremely hot.There was smoke coming from the d2 control unit and there were scorch marks left on the theatre towels.Follow up received indicated that the patient's post-operative condition is fine.There was no harm to the patient during the case.Back up devices and stacking system were available and used to complete the procedure without any delays.Reference (b)(4) for incisor plus blade and (b)(4) for the hand controller.

Manufacturer Narrative

One service replacement dii control unit part number 72200873s was received on (b)(4) 2015 and confirmed to be serial number (b)(4).A visual inspection was performed on the exterior of product and no damage was found.Complaint of smoke could not be reproduced but a burnt resistor r54 was found on main pcb.This was a result of the hand piece used by customer that jammed and overheated, causing r54 to sustain physical damage (bubble on resistor casing).Damaged main pcb did not affect functional ability of control unit.Product passed functional testing per process summary (b)(4) and 24 hour burn-in.No faults or errors occurred during functional testing and no burnt smell or overheating occurred.All functions perform as expected.(b)(4).

• Brand Name: DII CONTROLLER
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5003999
• MDR Text Key: 24245042
• Report Number: 1643264-2015-00104
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2013
• 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