MAUDE Adverse Event Report: AESCULAP INC DECKER RONGEURS 2X6MM STR 152MM; BONE PUNCHES, RONGEURS

Model Number	MF055R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.
Event or Problem Description
It was reported to aesculap inc.That a decker rongeurs 2x6mm str 152mm (part # mf055r) was used during lumbar discectomy and foraminotomy procedure performed on (b)(6) 2021.According to the complaint description, the surgeon was using the instrument during the case and the tip broke off and was retained in the patient.There was a 30 min delay in the surgery.Further information was received on apr 13, 2021.Additional intervention was required, longer procedure time and x-ray time for the surgeon to try and recover the broken piece.The broken piece is still in the patient.The patient outcome is unknown.The complaint device was returned to manufacture for evaluation.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: the device was sent back to the manufacturer for further evaluation.They conducted dimensional, visual, hardness, and functional testing on the device.All tests determined, that the device was conforming to its specifications.A definitive root cause was not able to be determined.Potential causes for the tip breaking off could be excessive force or torquing applied to the working end of the device by the user.Corrective action: corrective or preventive action was not deemed necessary, since the error was not attributed by a manufacturing error.And there have been no previous occurrences.

• Brand Name: DECKER RONGEURS 2X6MM STR 152MM
• Common Device Name: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 11739702
• Report Number: 2916714-2021-00063
• Device Sequence Number: 3029323
• Product Code: HAE
• UDI-Device Identifier: 04046964202308
• UDI-Public: 4046964202308
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: MF055R
• Device Catalogue Number: MF055R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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