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

Model Number FF805R

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/02/2023

Event Type  Injury  

Event Description

It was reported to aesculap inc.That a love-gruenwald rongeurstr3x10mm180mm (part # ff805r) was used in a l5-s1 microdiscectomy procedure on (b)(6) 2023.According to the complainant a fragment of the device had broken off during the procedure.The broken piece was recovered from the patient and was an exact match with the broken instrument.The patient underwent an x-ray which confirmed that there was no additional fragments.No further patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

Investigaiton complete.

• Brand Name: LOVE-GRUENWALD RONGEURSTR3X10MM180MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17133753
• MDR Text Key: 317210850
• Report Number: 2916714-2023-00063
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 04038653044597
• UDI-Public: 4038653044597
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/15/2023,07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2023
• Distributor Facility Aware Date: 05/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention