MAUDE Adverse Event Report: AESCULAP AG DET.RONGEUR STANDARD STR 3.0/180MM; BONE PUNCHES, RONGEURS

Model Number FH813B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 the rongeur.During a nucleotomy, the rongeur broke apart.It occurred while trying to remove a calcified intervetebral disc prolapse.The procedure was completed successfully.There was not a surgical delay of more than 15 minutes.A standard x-ray was done and confirmed that nothing remained in the patient's body.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: internal notification number: (b)(4); device reference code fh813b; device name det.Rongeur standard str 3.0/180mm; serial number n/a; batch number 52382814; udi device identifier (b)(4); udi production identifier (b)(4); basic udi-di n/a.Unit of use udi-di 4046964608186 manufacturing date 18.12.2017 failure description - the moveable handle is detached, since the push button is broken off from the locking.Investigation - vigilance investigator carried out the pictorial documentation visually1 and microscopically2.Signs of friction on the handle part which enters to the box lock are found during investigation.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.Batch history review - the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause - 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.Rationale - the breakage of the push button was most likely caused by an overload situation, probably torsion.It is convincible that the customer thought the push button is a screw and tried to disassemble the push button by unscrew it.Some competitor products are working this way.Therefore, there is the possibility that the customer tried to unscrew the push button and damaged the instrument.Furthermore the signs of friction on the handle part could have been caused by a insufficient lubrication, which in consequence can cause a higher friction when activating the push button.So higher forces are needed.Corrective action - according to sop sa-de13-m-4-2-04-000-0 a capa (corrective and preventive action) is not necessary.

• Brand Name: DET.RONGEUR STANDARD STR 3.0/180MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9565387
• MDR Text Key: 179479414
• Report Number: 9610612-2019-00898
• 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: 01/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FH813B
• Device Catalogue Number: FH813B
• Device Lot Number: 52382814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1