MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI DRILL ATTACHM.LARGE JACOBS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	GB638R
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that an acculan 3ti drill attachm.Large jacobs (part # gb638r) was used during a total knee arthroplasty (tka) navigation surgical procedure performed on (b)(6) 2021.According to the complainant, following the osteotomy of the proximal tibia, as the physician attempted to pin the distal femur osteotomy block, the device motor rotated for 1 to 2 seconds, and then stopped.The battery and attachment were replaced, but the issue recurred.The surgery was successfully completed using another type of device.The complaint device was returned to the manufacturer for evaluation.This event/malfunction prolonged the surgery for approximately ten (10) minutes.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00156 ((b)(4) + ga672), 9610612-2021-00160 ((b)(4) + gb636r), and 9610612-2021-00168 ((b)(4) + ga675).
Additional Manufacturer Narrative
Based upon new information received, this event was re-evaluated.And is considered no longer reportable.Changed to involved component.

• Brand Name: ACCULAN 3TI DRILL ATTACHM.LARGE JACOBS
• 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: 11475575
• Report Number: 9610612-2021-00159
• Device Sequence Number: 4523609
• Product Code: HWE
• UDI-Device Identifier: 04038653408214
• UDI-Public: 4038653408214
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: GB638R
• Device Catalogue Number: GB638R
• Device Lot Number: 51926308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR