MAUDE Adverse Event Report: AESCULAP AG DET.RONGEUR SEMI-SERR.150UP 3.0/200MM; BONE PUNCHES, RONGEURS

Model Number FH973B

Device Problem Solder Joint Fracture (2324)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation on going.Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with product det.Rongeur.According to the customer description, it was reported that the screw was broken.The patient harm is unknown.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report, the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: without product received, it is not possible to check the device quality and manufacturing history records.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.In the event, that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results, a capa is not necessary.

• Brand Name: DET.RONGEUR SEMI-SERR.150UP 3.0/200MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10779937
• MDR Text Key: 248938222
• Report Number: 9610612-2020-00603
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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: FH973B
• Device Catalogue Number: FH973B
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1