MAUDE Adverse Event Report: AESCULAP AG KERRISON BLK COATED 130 UP 200X5MM REG; BONE PUNCHES

Model Number	FK916B
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a kerrison blk coated 130 up 200x5mm reg (part # fk916b) was used during a procedure performed on an unknown date.According to the complainant, the instrument malfunctioned.Reportedly, the clamp blocked three times on all three uses and was not able to close.A problem with the clamp assembly was initially suspected, but was ruled out.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: investigation was carried out visually and microscopically.Seizure marks can be found both on the sliding block and on the t-slot.Therefore, a smooth running is no longer given.The instrument provided was in a used condition.The mechanical function was no longer given, the slider is seized up.The instrument could only be dismantled with the use of high force and oil.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 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: insufficient lubrication and/or foreign bodies lead to corrosion of the metallic friction surfaces/instrument components that move relative to each other (especially in ends/joints and sliding rails, e.G.With punches).To avoid metallic friction instructions for processing must be observed (see brochure "reprocessing of instruments to retain value").Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the problem is most probably reprocessing- related.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: KERRISON BLK COATED 130 UP 200X5MM REG
• Common Device Name: BONE PUNCHES
• 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: 12778720
• Report Number: 9610612-2021-00709
• Device Sequence Number: 12268462
• Product Code: LRY
• UDI-Device Identifier: 04038653412020
• UDI-Public: 4038653412020
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: FK916B
• Device Catalogue Number: FK916B
• Device Lot Number: 4512428432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown