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

Model Number GB638R

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event 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).

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
• Type of Device: 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
• MDR Text Key: 266713365
• Report Number: 9610612-2021-00159
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 04038653408214
• UDI-Public: 4038653408214
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR