MAUDE Adverse Event Report: AESCULAP AG DET.RONGEUR SEMI-SERR.150UP 3.0/150MM; BONE PUNCHES, RONGEURS

Model Number FH953B

Device Problems Material Erosion (1214); Peeled/Delaminated (1454)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

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 a rongeur.According to the complaint description the coating of the instrument peels off.The patient harm is unknown.Additional information has been requested but not yet received as of this report.The malfunction is filed under b)(4).

Manufacturer Narrative

Visual investigation: in our investigation we could find the described damages on the surface, the surface is scratched and therefore the black coating is partly damaged, too.The coating cannot flake of, the only way to damage the coating is by damaging the carrier material.Furthermore we found signs of friction on the sliding surface.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.Conclusion and measures / preventive measures: on the basis of the current information and the investigation results, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error.Based on the investigations and results of the 8d report a capa is not necessary.

• Brand Name: DET.RONGEUR SEMI-SERR.150UP 3.0/150MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10482858
• MDR Text Key: 206859983
• Report Number: 9610612-2020-00477
• Device Sequence Number: 1
• Product Code: HTX
• 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
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FH953B
• Device Catalogue Number: FH953B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1