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

Model Number FF805R

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

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 Description

Clarification: the patient harm was unknown.

• Brand Name: LOVE-GRUENWALD RONGEURSTR3X10MM180MM
• Type of Device: 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
• MDR Text Key: 289332820
• Report Number: 9610612-2022-00019
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 04038653044597
• UDI-Public: 4038653044597
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1