MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 2X12MM185MM; MICRO NEUROSURGICAL INSTR. / D

Model Number FF562R

Device Problem Material Fragmentation (1261)

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

Event Date 11/25/2022

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 ff562r - caspar rongeurstrserr 2x12mm185mm.According to the complaint description, the tip of the instrument break during disc disection and a part of the instrument fell in body of patient.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: visual investigation: the product arrived in a very used, decontaminated condition.The movable, upper mouth was broken off and was not available to us for examination.During the examination of the instrument, there were found heavy signs of use in the form of scuff marks, knock marks, and scratches.Silicate coatings, most likely from reconditioning, can be found on the entire surface.The fracture surface showed a force fracture.On the opposite side (fixed jaw) there is damage to the teeth.The hardness test resulted in a value which meets the specifications.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.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)) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard, 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.In order to be able to make a more precise statement, the broken jaw should be made available for examination.Since this instrument was not delivered in this condition because they do not comply with the aag standard, the cause can in all probability be found in the handling, but this cannot be clearly proven.The reason for the deviation cannot be determined.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably caused by an overload situation because these instruments are sensitive to lateral loads such as torsional and lever forces or impacts.Based upon the investigations results a capa is not necessary.

Event Description

The adverse event is filed under aag reference (b)(4).

• Brand Name: CASPAR RONGEURSTRSERR 2X12MM185MM
• Type of Device: MICRO NEUROSURGICAL INSTR. / D
• 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: 15933684
• MDR Text Key: 305000887
• Report Number: 9610612-2022-00366
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF562R
• Device Catalogue Number: FF562R
• Device Lot Number: 4510750594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• 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