MAUDE Adverse Event Report: AESCULAP AG ELAN 4 1-RING DIAMOND BURR D1.0; HIGHSPEED POWER SYSTEMS

Model Number GP143R

Device Problem Break (1069)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with gp143r - elan 4 1-ring diamond burr d1.0.According to the complaint description, the neck of the bar was broken during the surgery.There was no described patient harm.This malfunction occurred during a laminoplasty of the cervical spine additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: visual inspection - the investigation was carried out visually and microscopically.The investigation shows us that the burr head is broken.We assume the user used it with an overloading during handling.We detected that the burr was worn out.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 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Manufacturer Narrative

Based upon investigation results (previously submitted), this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.Failure mode within risk analysis updated after investigation; new severity is now 2(5) and no longer 3(5).

• Brand Name: ELAN 4 1-RING DIAMOND BURR D1.0
• Type of Device: HIGHSPEED POWER SYSTEMS
• 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: 12121808
• MDR Text Key: 265657488
• Report Number: 9610612-2021-00478
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GP143R
• Device Catalogue Number: GP143R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1