MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL MDU CNTRL PWRMX ELITE; STAPLE, FIXATION, BONE

Catalog Number 72200616SR

Device Problem Overheating of Device (1437)

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

Event Date 02/27/2017

Event Type  malfunction  

Event Description

It was reported that the mdu got hot.No patient injury was reported.

Manufacturer Narrative

Investigator determined that there was no relationship found between the returned device and the reported incident; consequently, investigator was unable reproduce and confirms the reported overheating failure mode.Product passed functional and high speed testing (100-10,000 rpms) for 5 minutes each in forward, reverse and oscillate directions.Unit passed functional tests on the dyonics power, dii and dii eip test control units with and without footswitch.Current draw was average for this product and overheating did not occur during functional testing.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: SVCE REPL MDU CNTRL PWRMX ELITE
• Type of Device: STAPLE, FIXATION, BONE
• 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7331341
• MDR Text Key: 102197907
• Report Number: 1643264-2018-00207
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00885556582305
• UDI-Public: (01)00885556582305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 04/24/2018
• 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