MAUDE Adverse Event Report: AESCULAP AG ACTIV L REVISION DISTRACT.FORCEPS ANGLED; INSTRUMENTS SPINAL MOTION

Model Number	FW965R
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
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 that there was an issue with the product activ l revision distract forceps angled.Specifically, it was reported that the surgeon placed the distractor into the implant in an attempt to open the implant to retrieve the poly insert.Upon full distraction, the tip of the distractor bent and the instrument could not be used as intended.The scrub technician attempted to straighten the bent tip at which point the tip broke away from the instrument.The surgeon used a nuvasive paddle distractor to open the disc space.The broken tip was never inside the wound and was then thrown away.There was no patient harm.This malfunction prolonged the surgery for 20 minutes.Additional information has been requested but not yet received as of the date of this report.The malfunction is filed under aag reference xc (b)(4).
Additional Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: ACTIV L REVISION DISTRACT.FORCEPS ANGLED
• Common Device Name: INSTRUMENTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10271556
• Report Number: 9610612-2020-00290
• Device Sequence Number: 3370927
• Product Code: MJO
• UDI-Device Identifier: 04038653431441
• UDI-Public: 4038653431441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/18/2021

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: FW965R
• Device Catalogue Number: FW965R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 96