MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616S

Device Problem Hole In Material (1293)

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

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The reported complaint of a hole in the power cord insulation could not be confirmed.A small nick was found on the cord insulation but no bare wiring was visible.Product passed all functional tests.Unit was tested at speed settings between 100 and 10,000 rpm¿s in forward and reverse for 5 minutes each.Also oscillate for 5 minutes in highest setting (9).Product was tested on a known good dyonics power, dii, and dii eip control units with and without footswitch.All functions perform as expected.No problem found.A review of the manufacturing records shows that this unit was released to distribution on or about june 11, 2015.Cosmetic damage to cord occurred at customer site since customer has had mdu for almost 2 years.

Event Description

It was reported that during a procedure a hole was discovered in the insulation.This observation did not result in any delays.A backup device was available for use.No patient or user injury was reported.

• Brand Name: SVC REPL,MDU, HAND CNTRL, PWRMX
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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 ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6537063
• MDR Text Key: 74407324
• Report Number: 1643264-2017-00246
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616S
• Device Lot Number: AAL59643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1