MAUDE Adverse Event Report: AESCULAP AG CUSHING RONGEUR STR 2X10MM180MM; BONE PUNCHES, RONGEURS

Model Number FF803R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results are provided, they will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with a rongeur via information received from medwatch (b)(4).According to the complaint description, the instrument tip broke off while in use during a discectomy procedure.Surgeon found tip and both pieces were removed from the field.A portable x-ray was taken in operating room prior to final count and closure.No metal fragments confirmed by examination of results in reading room.Additional information was not provided but has been requested.The event occurred in (b)(6) 2020.The adverse event / malfunction is filed under xc reference (b)(4).

Event Description

No change.

Manufacturer Narrative

Manufacturing site evaluation: 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.The device history records (dhr) were not able to be reviewed as no lot number was provided for analysis.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: CUSHING RONGEUR STR 2X10MM180MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10984198
• MDR Text Key: 220712332
• Report Number: 2916714-2020-00713
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 04038653044580
• UDI-Public: 4038653044580
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 12/10/2020,03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF803R
• Device Catalogue Number: FF803R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2020
• Distributor Facility Aware Date: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention