MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	GB109
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap ag that a microline straight handpiece (part # gb109) was used during an oral surgery procedure performed on (b)(6) 2020.According to the complainant, the device generated heat when used in combination with another manufacturers bar.Reportedly, a large swollen burn occurred on the back of the patient's lips.The complaint device was available to be returned to the manufacturer for evaluation.Additional information was requested, but has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
The device was returned to the manufacturer for physical evaluation.A visual examination of the returned device revealed, the handpiece to be in very bad condition.The interior was very dirty and the front ball bearing was broken.Overheating would be likely, due to the defective ball bearing.Which would have resulted in an inability to clamp the tool properly.The investigation into the cause of the reported problem was able to confirm the failure mode of overheating.The complaint investigator identified a damaged front ball bearing.Which likely resulted, in the handpiece overheating.As such, the reported complaint of device overheating was confirmed.

• Brand Name: MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10952337
• Report Number: 9610612-2020-00854
• Device Sequence Number: 3056326
• Product Code: HWE
• UDI-Device Identifier: 04038653241132
• UDI-Public: 4038653241132
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GB109
• Device Catalogue Number: GB109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1