MAUDE Adverse Event Report: AESCULAP AG DET.RONGEUR SEMI-SERR.STR 3.0/230MM; BONE PUNCHES, RONGEURS

Model Number FH883B

Device Problem Break (1069)

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

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the device was not provided for investigation.Therefore, a investigation of the device itself was not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Based on the provided information, and without a product for investigation, a clear conclusion can not be drawn.Based on the investigations, and results of the 8d report no capa is necessary.

Event Description

It was reported that there was an issue with a det.Rongeur semi-serr.Str 3.0/230mm.According to the complaint report a screw of the rongeur broke during surgery.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference: (b)(4).Associated medwatch-report: 9610612-2020-00208 (400473321 - fh973b).

• Brand Name: DET.RONGEUR SEMI-SERR.STR 3.0/230MM
• Type of Device: BONE PUNCHES, RONGEURS
• 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: 10779716
• MDR Text Key: 215500436
• Report Number: 9610612-2020-00546
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FH883B
• Device Catalogue Number: FH883B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1