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

Model Number	FF805R
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap ag that an love-gruenwald rongeur (part # ff805r) was used during a procedure performed on an unknown date.According to the complainant, the pin from the joint fell out during the procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Additional information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch reports: 9610612-2022-00019, 9610612-2022-00039.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Associated medwatch reports: 9610612-2022-00019, 9610612-2022-00039.Investigation: visual investigation: we made a visual inspection of the products, and here we detected a broken off tip on the products.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device was 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.Explanation and rationale: according to the quality standard, a production error and a material defect can most probably be excluded.Investigations lead to the assumption that the broken off tip was caused due to overload situation during handling, e.G.Torsion or leverage.If the surgeon grabs too much or twists the instrument during grabbing, there is the possibility that the tip of the product broke off.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 on the investigation results, a capa is not required.
Event or Problem Description
Clarification: the patient harm was unknown.

• Brand Name: LOVE-GRUENWALD RONGEURSTR3X10MM180MM
• Common Device Name: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13516028
• Report Number: 9610612-2022-00019
• Device Sequence Number: 5299813
• Product Code: HTX
• UDI-Device Identifier: 04038653044597
• UDI-Public: 4038653044597
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown