MAUDE Adverse Event Report: AESCULAP AG CUSHING RONGEUR STR 2X10MM180MM; BONE PUNCHES, RONGEURS

Model Number FF803R

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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 cushing rongeur.The jaw was broken during surgery on the bone according to the report.There was no patient harm.An additional medical intervention was not necessary.This malfunction prolonged the surgery for 5 minutes.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.During investigation the breakage surfaces of the broken remained part on the instrument has been analysed.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Furthermore the mouth shows several damages on the cutting edge and its lateral parts.Batch history review: the device quality and manufacturing history records for the available lot number has been requested at the responsible q-coordinator of the production plant.The answer is still pending, the 8d-report will be updated upon receipt of the review-confirmation.No similar incidents have been filed with products from this batch.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) 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.

Event Description

The malfunction is filed under aag reference (b)(4).

• Brand Name: CUSHING RONGEUR STR 2X10MM180MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9286210
• MDR Text Key: 178639077
• Report Number: 9610612-2019-00746
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF803R
• Device Catalogue Number: FF803R
• Device Lot Number: 4507865799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1