MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 3X12MM160MM; BONE PUNCHES, RONGEURS,

Model Number FF533R

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with ff533r - caspar rongeurstrserr 3x12mm160mm.According to the complaint description, the jaws of the instrument broke intraoperatively during a discectomy.The fragment was retrieved from the patient's body.There was no surgical delay.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

• Brand Name: CASPAR RONGEURSTRSERR 3X12MM160MM
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17196134
• MDR Text Key: 317809766
• Report Number: 9610612-2023-00152
• 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
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF533R
• Device Catalogue Number: FF533R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: No
• 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