MAUDE Adverse Event Report: AESCULAP AG ACTIV L INSERTION INSTRUMENT F/H8.5MM; ACTIV L INSTRUMENTS

Model Number	FW961R
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
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 fw961r - activ l insertion instrument f/h8.5mm during lumbar tdr procedure performed on (b)(6) 2021.According to the complaint description, the implant is sticking on inserter.Doctor requested replacement.There was no surgery delay and the patient was under anesthesia.The surgeon was able to continue the surgery with this instrument.It just wasn't holding as tight as it used to, so they want to replace it.There was no patient or implant impacted.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information - d9, h4.Based upon investigation results, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.Investigation results: visual investigation: we made a visual inspection of the received instrument, especially the implant- interface.Here we found one of the prongs damaged / deformed.A deformed prong leads to complications at the coupling- and decoupling of the implant.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 4(10) x probability of occurrence 4(10) according to din en iso 14971 is still acceptable.Explanation and rationale: the root cause for the described problem is a deformed/bent prong at the tip of the instrument.Conclusion and measures / preventive measures: based upon the investigation results, the instrument was in use since 2007.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ACTIV L INSERTION INSTRUMENT F/H8.5MM
• Common Device Name: ACTIV L INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11731436
• Report Number: 9610612-2021-00333
• Device Sequence Number: 14459737
• Product Code: MJO
• UDI-Device Identifier: 04038653425587
• UDI-Public: 4038653425587
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P120024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: FW961R
• Device Catalogue Number: FW961R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown