MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE, REPL, DRILL, POWER; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205785S

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that the device had a gearbox motor failure or internal short.No patient was involved.

Manufacturer Narrative

The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection observed that the device case is pitted and scratched.A functional evaluation revealed that the device cannot be recognized by a control unit.Functional evaluation for gear/motor failure could not be performed.The complaint was verified and the root cause was associated with an electrical component failure.Factors that could have contributed to the event include a component failure or an open circuit.The device is being sent to the original equipment manufacturer (oem) for further evaluation.If new information related to this complaint is received, this evaluation will be reopened for investigation.

• Brand Name: SERVICE, REPL, DRILL, POWER
• 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
• MDR Report Key: 7100181
• MDR Text Key: 94389668
• Report Number: 1643264-2017-01813
• 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: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205785S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• 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