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

Model Number FH973B

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

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 product det.Rongeur semi-serr.150°up 3.0/200mm.According to complaint description it was reported that hospital staff was using this instrument but screw was broken intraoperatively.There was no patient harm.Additional information was not provided nor available.The adverse malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

To date there is no device available for investigation.On the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the basis of the intern investigation.

Event Description

The adverse malfunction is filed under aag reference (b)(4).Associated aag reference: (b)(4) - fh883b - det.Rongeur semi-serr.Str 3.0/230mm.

• 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: 10155301
• MDR Text Key: 196838217
• Report Number: 9610612-2020-00208
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1