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

Catalog Number 72200616

Device Problem Circuit Failure (1089)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a case the device had a short circuit detected.No further information provided.It is unknown if there was a delay or back-up device available.No patient injuries reported.

Manufacturer Narrative

The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.Mdu failed functional tests with hand piece overload when power cord was bent/twisted.Power cord assembly grew warm during testing.It was determined that the power cord has shorted and/or open internal wiring.The motor and hall board were tested and passed functional testing.The complaint was confirmed and the root cause was determined to be an electrical component failure of the power cord.

• 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8439462
• MDR Text Key: 139450456
• Report Number: 1643264-2019-00213
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555472
• UDI-Public: 03596010555472
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• 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: 03/22/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2019
• 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: Unknown
• Patient Sequence Number: 1