MAUDE Adverse Event Report: AESCULAP AG DET.RONGEUR STANDARD 150UP 4.0/180MM; BONE PUNCHES, RONGEURS

Model Number FH914B

Device Problems Material Erosion (1214); Peeled/Delaminated (1454); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); 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.(b)(4).

Event Description

It was reported that there was an issue with a rongeur.According to the complaint description the surface quality changed.After 9 times of preparation the coating dissolves and the surface condition has changed.There are also unevennesses in the material.Found prior to use.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00458 ((b)(4) - fh913b), 9610612-2020-00459 ((b)(4) - fh912b).

Manufacturer Narrative

Investigation results: the device was available for investigation.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage, and in case of the friction found on the sliding surface by insufficient lubrication.The signs of friction and scratches found on the surface/coating are signs for the contact of the surface with other instruments or other hard surfaces during the reprocessing or the usage of the rongeurs.Regarding the described issues with fibres coming from the gauze used for intra-operative cleaning we want to inform, that gauze is not suitable for such a cleaning, as edges coming from the geometry of the mouth are part of the design and are not avoidable.There is no indication for a material defect or manufacturing failure on the baisis of the device history records.Based on the investigations and results of the 8d report no capa is necessary.

Event Description

The malfunction is filed under aag reference (b)(4)((b)(4)).Associated medwatch-reports: 9610612-2020-00459 ((b)(4)- fh912b); 9610612-2020-00458 ((b)(4)- fh913b).

• Brand Name: DET.RONGEUR STANDARD 150UP 4.0/180MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10480174
• MDR Text Key: 206960787
• Report Number: 9610612-2020-00457
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 04046964608278
• UDI-Public: 4046964608278
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FH914B
• Device Catalogue Number: FH914B
• Device Lot Number: 52593844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1