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

Model Number 72200616

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 10/04/2020

Event Type  malfunction  

Event Description

It was reported that before procedure, the mdu was not working.No delay and a competitor device was used to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.A review of the instructions for use revealed the following warnings and precautions related to the reported failure: 1) do not operate the handpiece in the open air for an extended period.Lack of irrigation may cause the motor or blade to overheat and seize.2) disconnect the handpiece cable from the front panel by pulling back the locking collar on the connector, then unplugging it from the control unit.Do not disconnect the cable from the handpiece.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 10734531
• MDR Text Key: 213036135
• Report Number: 1643264-2020-01612
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555472
• UDI-Public: 03596010555472
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200616
• Device Catalogue Number: 72200616
• Device Lot Number: AAL100048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention