MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER CABLE ASSEMBLY; SAW, POWERED, AND ACCESSORIES

Model Number	7205788
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was shorting.No patient injuries were reported.This failure was detected prior surgery.A backup was available.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.An evaluation was performed by smith & nephew.A visual inspection observed bent pins in the handpiece connector.The pins were not touching other pins or the housing.A functional test revealed the bent pins prevented insertion of the handpiece.The pins were straightened and the cable retested, no shorts were observed.The complaint was not confirmed.Factors that could have contributed to the failure include excessive force, misalignment, or twisting of the connector during connection/disconnection to a handpiece.

• Brand Name: DYONICS POWER CABLE ASSEMBLY
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7440250
• Report Number: 1643264-2018-00297
• Device Sequence Number: 11256766
• Product Code: HAB
• UDI-Device Identifier: 03596010408990
• UDI-Public: (01)03596010408990
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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
• Operator of Device: Health Professional
• Device Model Number: 7205788
• Device Catalogue Number: 7205788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1