MAUDE Adverse Event Report: AESCULAP AG BECK STR RONGEURS 2X140MM; BONE PUNCHES, RONGEURS

Model Number FF765R

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2022

Event Type  Injury  

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 ff765r - beck str rongeurs 2x140mm.According to the complaint description, the forceps broke during the removal of the herniated disc surgery.The lower jaw fell into the patient's surgical wound and was then retrieved.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: when we examined the instrument, we could see heavy signs of use in the form of scuffs, impact marks and scratches, the entire surface is darkly discolored, and silicate residues can be found which probably originate from reconditioning.Both jaws are broken off.The fracture surface shows a force fracture due to an overload situation which is also confirmed by the bending and deformation of the remaining segment.On one leg an unknown stamp is applied.In the space between the upper and lower part and at the joint of the working end, severe corrosion can be seen which could be caused by improper maintenance (too little or no lubrication by oil after the washing process).The hardness test resulted in a value of 46.1 hrc, which corresponds to the specifications.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 4(5) and probability 1(5)) according to din en (b)(4) is still acceptable; the current failure rate is within the risk analysis and therefore acceptable.Explanation and rationale: according to the quality standard and the age of the product, a material defect and a production defect can be ruled out with a high degree of probability.There are no indications of previous damage or similar.We can rule out a manufacturing-related cause based on the current analysis results.These devices are sensitive to lateral loads such as torsional and lever forces or impacts.Conclusion and measures / preventive measures: based upon the investigation results, in all probability, the damage was caused by an overload situation.This is also supported by the damage in the form of bending of the residual material which is why the cause in all probability lies in the handling, although this cannot be clearly proven.The reason for the deviation cannot be determined.Based upon the investigations results a capa is not necessary.

• Brand Name: BECK STR RONGEURS 2X140MM
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16135632
• MDR Text Key: 307063128
• Report Number: 9610612-2023-00001
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF765R
• Device Catalogue Number: FF765R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2004
• 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
• Patient Outcome(s): Required Intervention