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

Catalog Number 72200616SR

Device Problems Failure to Read Input Signal (1581); Sticking (1597)

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

Event Date 03/21/2017

Event Type  malfunction  

Event Description

It was reported that the reverse button got stuck during the case.No surgical delay or patient harm reported.It is not known at this time if the procedure was completed as no backup device was available.

Manufacturer Narrative

There was a relationship found between the returned device and the reported incident.The complaint of a reverse button malfunction was reproduced.The root cause was determined to be corrosion of the button magnet and spring.Factors which could have contributed to the failure include damage to the seals around the finger switch buttons which can lead to cleaning chemical fluid ingression over time.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: SVCE REPL MDU CNTRL PWRMX ELITE
• 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: 6480452
• MDR Text Key: 72677454
• Report Number: 1643264-2017-00200
• 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,Followup
• Report Date: 05/31/2017

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 Catalogue Number: 72200616SR
• Device Lot Number: AAL87358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• 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