MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 2X12MM160MM; MICRO NEUROSURGICAL INSTR. / D

Model Number FF532R

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/03/2023

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 the product ff532r - caspar rongeurstrserr 2x12mm160mm.According to the complaint description, the jaw broke intraoperatively, in the invertebral space.Due to the breakage, a metal fragment fell in the patient's body.After several attempts, the fragment was removed.This event occured during an unilateral lumbar recalibration procedure.Additional medical intervention was necessary.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: aesculap ag carried out a visual and microscopic examination.A repair stamp was found, indicating that the instrument had been repaired in france by aesculap technical service (ats).The movable jaw was broken off - the fragment, which could provide further clues as to the reason for the deviation, is not available.The fracture surface shows a forced fracture due to overloading.The hardness was tested and found to be 475 hv5, which is within the specification of 420 +110 hv5.Batch history review: there is no device history review indicated based on the fact that the affected device was repaired.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event is based on the patient harm, additional medical intervention.Conclusion/preventive measures: no evidence of material defects such as pores or inclusions were found.The cause could not be determined.Notes from the electronic instructions for use (eifu) ta011658 2020-10 v6 change no.62252 on this: damage or destruction of the jaws due to overload! - only use rongeurs as intended (i.E.Ablation of soft tissue).Do not cut or lever out bones or adjacent bone structures.- avoid overloading the jaws by tearing off or holding and levering tissue or by lateral loading through twisting, or lateral strain due to twisting.- do not use rongeurs with blunt cutting edges, send them in for repair.Do not remove more fabric than will fit into the openings of the jaws.Based upon the investigation results, a capa is not required.

Event Description

Update: extension of the operating time/increase in the number of radiographs for research and guidance of the extraction of the metal fragment.

• Brand Name: CASPAR RONGEURSTRSERR 2X12MM160MM
• 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: 18220874
• MDR Text Key: 329160533
• Report Number: 9610612-2023-00248
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF532R
• Device Catalogue Number: FF532R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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