MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURUP-BITESERR 3MM160MM; BONE PUNCHES, RONGEURS

Model Number FF543R

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: product has been received for investigation, fell off mouth part sent in together with instrument.The instrument is in a decontaminated condition.According to the available information, there were no negative consequences for the patient.The instruments upper mouth part is broken investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.During investigation the breakage surfaces of the broken mouth part and the remained part on the instrument have 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.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.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: according to the investigation results a material defect and production error can be excluded.Based on the analysis of the breakage surface, most probably the breakage was caused by an overload situation during the surgery.Corrective action: corrective action and preventive action is not necessary.

Event Description

It was reported that there was an issue with rongeur caspar.It was reported that one of the grasping parts broke off during operation.The instrument was not being used on hard tissue or bone.The broken part was immediately removed without problems.There was no patient harm.An additional medical intervention was not necessary.There was no surgery delay.Additional information was not provided nor available.The adverse event/malfunction is filed under (b)(4).

• Brand Name: CASPAR RONGEURUP-BITESERR 3MM160MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9348937
• MDR Text Key: 179251246
• Report Number: 9610612-2019-00795
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF543R
• Device Catalogue Number: FF543R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1