MAUDE Adverse Event Report: AESCULAP AG LOVE-GRUENWALD RONGEURSTR3X10MM180MM; BONE PUNCHES, RONGEURS

Model Number FF805R

Device Problem Break (1069)

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

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: no investigation method could be applied, because the product was not available.Therefore an investigation of the product was not possible.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.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.Based on the available information, no risk could be identified conclusion/preventive measures: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Based upon the investigation results, a capa is not required.

Event Description

It was reported that there was an issue with the product ff805r - love-gruenwald rongeurstr3x10mm180mm via information recieved from mw5117648.According to the complaint description, the device broke during an l5-s1 discectomy procedure.The piece was retrieved from the patient; the fragment was an "exact match" with the broken instrument.X-ray results confirmed that there were no other foreign bodies.There were no other complications and the condition of the patient was noted as stable; discharge from the hospital occurred the same day.An additional medical intervention was required.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

• Brand Name: LOVE-GRUENWALD RONGEURSTR3X10MM180MM
• 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: 17233240
• MDR Text Key: 318177150
• Report Number: 9610612-2023-00151
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF805R
• Device Catalogue Number: FF805R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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