MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Device investigation narrative - one powermax elite motor drive unit, part number 72200616 was received on july 14, 2017 and confirmed to be serial number (b)(4) as reported in the complaint.The reported complaint of shorting out could not be confirmed.Product did not short out during functional testing.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.At no time did mdu short out or overheat.All functions perform as expected.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.(b)(4).

Event Description

It was reported that the mdu shorted out during the procedure.A backup device was available to complete the procedure.

• Brand Name: MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 6726307
• MDR Text Key: 80549580
• Report Number: 1643264-2017-00420
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• 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