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

Model Number 72200616

Device Problems Partial Blockage (1065); Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).It is reported that on discussion with the surgeon later that day, he described what he thought had happened to be 'metallosis' which apparently is common in orthopedic and trauma-type surgeries.This occurs when high frictional forces of metal against metal causes one or both of the metal surfaces to shear into tiny particles which then stains any fluid it comes into contact with, turning it black.(b)(4).

Event Description

Reportedly, foot and ankle orthopedic surgeon was performing an ankle arthroscopy on a male patient and required the use of a 4.5mm incisor plus shaver blade for soft tissue removal.This shaver blade was connected to the hand piece in question and initially worked fine.All of a sudden there was a high pitched screeching/whirring sound coming from the hand piece as if something had come loose inside and was blocking the mechanism inside, causing a huge amount of friction while still attempting to work.The surgeon noticed a black residue (which looked like black fluid) coming out of the tubing attached at the suction port and immediately pulled the shaver out from the joint.On pulling the shave out, a small drop of the black residue/fluid ran down the shaver blade and entered the joint which was noticeable on the monitor.At this point the joint was flushed with saline and a new shaver and hand piece were opened to complete the procedure.The scrub nurse stated that she looked inside the hand piece after removing the blade and there was a large amount of black residue that seemed to be bubbling.The patient was provided with additional antibiotic cover and was informed of the incident once back in the ward.

Manufacturer Narrative

Evaluation narrative - the subject device, one service replacement powermax elite, part number 72200616s was received on november 12th, 2015 and confirmed to be serial number (b)(4).The reported complaint could only be confirmed in part.Unit failed functional testing and gave a ¿motor stall¿ error message when using a d2 control unit.Further inspection has found the motor has seized and will not rotate.Disassembly of the motor was not possible as the motor is stuck inside the housing as a result of internal corrosion.It appears that this unit has leaked over time as a result of exposure to cleaning and sterilization.The root cause of the reported ¿high pitched screeching/whirring sound¿ is most likely associated with the seized motor.The report of ¿black residue¿ coming from the motor could not be confirmed, no residue was found.A document review has found that serial number (b)(4) was manufactured in november of 2013.The complaint investigation has concluded that this unit has succumbed to expected wear and tear.(b)(4).

• 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: james gonzales ; 130 forbes boulevard; mansfield, MA 02048 ; 5123585706
• MDR Report Key: 5236342
• MDR Text Key: 31616428
• Report Number: 1643264-2015-00174
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2013
• 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
• Patient Outcome(s): Other