MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEUR UP-BITE 3MM155MM; BONE PUNCHES, RONGEURS

Model Number FF843R

Device Problem Material Fragmentation (1261)

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

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 ff843r - caspar rongeur up-bite 3mm155mm.According to the complaint description, a part of the device broke off during surgery.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results visual investigation vigilance investigator carried out the pictorial documentation visually and microscopically.The breakage surface of the broken mouth part and the rested part on the joint is showing different colours on the outer area and on the centre.This phenomenon shows that there has been an earlier crack which cracking surface got discoloured during the reprocessing process.The shiny breakage surface shows the actual breakage which was caused by a overloading.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.There are no similar complaints against the same lot number(s) with this error pattern.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) probability of occurrence1(5)) 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.Due to the age of the instrument (> 10 years), the different colors found on the breakage surface and the signs of corrosion on the gap between mouth part and shaft we assume, that the breakage was caused by a long term combination of overload and reprocessing.We were not able to detect any hints for a material or manufacturing defects.The more dark area on the breakage surface is caused by a strong passivation layer, which means it was created a longer time ago.Most frequent reason for such cracks is excessive force.The remainder of the material, more bright area shows a fine homogenous crystal structure and was created by an overload fracture.Based upon the investigations results a capa is not necessary.

• Brand Name: CASPAR RONGEUR UP-BITE 3MM155MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11496587
• MDR Text Key: 253216933
• Report Number: 9610612-2021-00175
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF843R
• Device Catalogue Number: FF843R
• Device Lot Number: 4503920410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1