MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEUR UP-BITE 3MM155MM; BONE PUNCHES, RONGEURS

Model Number	FF843R
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with ff843r - caspar rongeur up-bite 3mm155mm.According to the complaint description, a rongeur with reference ff843r is broken during a spine surgery on (b)(6) 2017.A piece of the rongeur remained in the body of the patient.A revision surgery was necessary.Additional information received confirmed that the specific piece of the rongeur has been removed (d.D.End (b)(6)/beginning of (b)(6)).The adverse event is filed under (b)(4).
Additional Manufacturer Narrative
Updated e1: initial reporter.Updated h6: codes.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: CASPAR RONGEUR UP-BITE 3MM155MM
• Common Device Name: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11923458
• Report Number: 9610612-2021-00417
• Device Sequence Number: 804896
• Product Code: HTX
• UDI-Device Identifier: 04038653044719
• UDI-Public: 4038653044719
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: FF843R
• Device Catalogue Number: FF843R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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