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

Model Number	FF803R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results are provided, they will be submitted in a supplemental report.
Event or Problem 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 or Problem Description
No change.
Additional 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
• Common Device Name: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10984198
• Report Number: 2916714-2020-00713
• Device Sequence Number: 3240761
• Product Code: HTX
• UDI-Device Identifier: 04038653044580
• UDI-Public: 4038653044580
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021
• Report Date (Section F): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FF803R
• Device Catalogue Number: FF803R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 12/10/2020