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

Model Number FF843R

Device Problems Break (1069); Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event 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).

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
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11923458
• MDR Text Key: 264857082
• Report Number: 9610612-2021-00417
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 04038653044719
• UDI-Public: 4038653044719
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF843R
• Device Catalogue Number: FF843R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention