MAUDE Adverse Event Report: AESCULAP AG MICROLAN 100 PNEUMATIC MOTOR; HIGHSPEED POWER SYSTEMS

Model Number GA553

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a ga553 - microlan 100 pneumatic motor.According to the complaint description the motor does not hold during surgery.The motor flew apart when trying to drill.There was no patient harm.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: ga513r - air hose 3.0m aesc.-draeger/aesc.Small - lot 52115461, ga740r - hilan xs pneumatic motor - lot 4502480265, ga508r - air hose adapter angled f/aesculap small - lot unknown, ga742r - hilan pneumatic perforator driver - lot 4502627327.

Manufacturer Narrative

Investigation results: ga553: the claimed ga553 #919 was delivered in december 2009, a repair or maintenance cannot be found within our database.Optically the product is in a used condition, traces of use are visible.The trepanation engine did not show any deviations during the functional test.The motor power and the heating are ok.Tool locking and hose connection are fully functional.The product is without defects.Ga513r: the claimed ga513r #4122 was delivered in april 2015, the last repair/maintenance was done executed in february 2020.Visually the product is in good condition, only small traces of use are visible and the exhaust hose is slightly twisted.Also during the function test the compressed air hose showed no deviations.The slightly twisted exhaust air hose has no negative effect and is due to twisting when inserted into the storage sieve.The product is without defects.Ga740r: the claimed ga740r #2395 was delivered in december2009, the last repair/maintenance was carried out in september 2020.Visually the product is in good condition, only small traces of use are visible (chafe marks on the hose connection).Even during the function test, the air motor showed no deviation in the power range, values and temperature were ok.Only in the idle speed range, i.E.In the "o" position (without tools), the motor continued to run slightly at normal speed.Motor cell is misaligned and must be replaced.This defect has nothing to do with the described error.Ga508r: no date of manufacture or delivery can be traced for the ga508r #953.A maintenance/repair was carried out in september 2020.Optically the product is in good condition, only small traces of use can be seen and the balls of the lock are discolored.Even during the functional test the ga508r adapter showed only slight deviations.Due to the discoloration of the balls, the surface condition is damaged.Due to the "dull" surface of the balls, the sliding function is no longer guaranteed.With the described error (motor has been blown apart) it is quite possible that the circlip securing the ga508r adapter on the ga740 motor was not correctly applied.The damaged surface of the balls makes it difficult to lock the two components together and it is therefore quite possible that the motor fell off during the surgery.The reason for the discoloration/damage of the ball surface is not comprehensible.A material defect of the balls is to be excluded at present, neither with complaints, nor with repairs/maintenance these deviations occurred in the past.Ga742r: the claimed ga742r #381 was delivered in june 2010, the last repair/maintenance was done in april 2020.Optically the product is in a good and nearly new condition, only small traces of use are visible.The trepanation motor showed no deviations during the functional test.The motor power and the heating are ok.Tool locking and hose connection are fully functional.The product is without defects.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 3 out of 5 probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results there is capa is not necessary.

Event Description

Update received: after usual function test and using directly on the patient, the handpiece tore off the drill hose.The drill hose, which was under compressed air, hit the surgeon's head.All components of the drill were removed from the surgery and a new drill was used.No damage to surgeon.Surgery delay with few minutes reported.A replacement drill was organized.

• Brand Name: MICROLAN 100 PNEUMATIC MOTOR
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10764290
• MDR Text Key: 239830337
• Report Number: 9610612-2020-00811
• Device Sequence Number: 1
• Product Code: GET
• 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
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA553
• Device Catalogue Number: GA553
• Device Lot Number: 51585389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GA508R; GA513R; GA740R; GA742R