MAUDE Adverse Event Report: AESCULAP AG LOVE-GRUENWALD RONGUP-BITE3X10MM180MM; BONE PUNCHES, RONGEURS

Model Number FF806R

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

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 ff806r - love-gruenwald rongup-bite3x10mm180mm.According to the complaint description, the love-gruenwald rongeurstr3x10mm180mm biting tip bent on very first use in surgery.No fragment only tip bent.The device malfunction was noted on (b)(6) 2021.There was no patient involvement and the device malfunction did not cause or contribute to a delay in a surgery.The device is available for evaluation.This complaint involves one (1) device.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00151 ((b)(4) +ff805r).

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 Description

Associated medwatch-reports: 9610612-2021-00151 ((b)(6) +ff805r) and 9610612-2021-00152 ((b)(6) +ff806r).

• Brand Name: LOVE-GRUENWALD RONGUP-BITE3X10MM180MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11445680
• MDR Text Key: 266710459
• Report Number: 9610612-2021-00152
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 04038653044603
• UDI-Public: 4038653044603
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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
• Device Operator: Health Professional
• Device Model Number: FF806R
• Device Catalogue Number: FF806R
• Device Lot Number: 4511773758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1