MAUDE Adverse Event Report: AESCULAP AG LOVE-GRUENWALD RONGEURSTR3X10MM180MM; BONE PUNCHES, RONGEURS

Model Number	FF805R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
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 to aesculap that a love-gruenwald rongeurstr3x10mm180mm (part # ff805r) and a love-gruenwald rongup-bite3x10mm180mm (part # ff806r) were used during an unknown procedure performed on (b)(6) 2021.According to the complainant, the biting tips of both devices were bent during the first use in a surgical procedure.No fragments detached from either device.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Additional information was not provided.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00152 ((b)(4) + ff806r).
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results/ visual investigation: investigation was carried out visually and microscopically.We found misaligned deformed upper jaws.Investigations lead to the assumption that the misaligned deformed upper jaws were caused by an improper handling due to a mechanical overload situation.Possibly an excessive force has been applied on the instrument or the possibility of torsion with the instrument.Furthermore this has to be observed according to the istruction for use.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) 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.Based upon the investigations results a capa is not necessary.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00151 ((b)(6) +ff805r) and 9610612-2021-00152 ((b)(6) +ff806r).

• Brand Name: LOVE-GRUENWALD RONGEURSTR3X10MM180MM
• Common Device Name: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11455610
• Report Number: 9610612-2021-00151
• Device Sequence Number: 3523945
• Product Code: HTX
• UDI-Device Identifier: 04038653044597
• UDI-Public: 4038653044597
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FF805R
• Device Catalogue Number: FF805R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1