MAUDE Adverse Event Report: AESCULAP AG KERRISON DETACH 130DG UP 200MM 1MM THIN; MICRO NEUROSURGICAL INSTR.

Model Number	FK961B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, they will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with a kerrison.The tip of the device broke during use in a c4-c6 anterior cervical discectomy and fusion (acdf) procedure.The broken fragment was successfully retrieved from the patient as the piece was easily visible.An x-ray was not required; there was less than 5 minute delay required to replace the instrument.Additional information was not available.The fragment was noted to be extremely small.The adverse event is filed under xc reference (b)(4).
Additional Manufacturer Narrative
B3, d4 and f8 - updated product available for investigation in a decontaminated condition.Failure description the kerrison punch shows a broken footplate.Investigation vigilance investigator carried out the pictorial documentation visually and microscopically.The footplate is totally broken off.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Batch history review the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number with this error pattern.Explanation and rationale the failures found in our investigation are showing clear signs of an overload situation during the procedure itself.Especially the 1 mm kerrison require to avoid overload situations as they are designed for delicate use only (see hints in instructions for use (ifu)).We were not able to detect any hint for a material defect or a production error.Per ifu: warning - figure 5 - hints regarding overload damage to, or destruction of the product caused by incorrect handling! - use the product according to its intended use - avoid overstraining the product by turning or levering movements during the punching procedure (especially applies to kerrison bone punches with thin foot plate) - use kerrison bone punches with the thin foot plate only for removing small, soft bone parts and soft tissue - punch out only as much tissue as the cavity between the foot and slider part can accomodate conclusion and root cause due to the current deviation and according explanation and rationale above, the root cause of the problem is most probably usage-related.A capa is not necessary.
Event or Problem Description
No updates.

• Brand Name: KERRISON DETACH 130DG UP 200MM 1MM THIN
• Common Device Name: MICRO NEUROSURGICAL INSTR.
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11856173
• Report Number: 2916714-2021-00114
• Device Sequence Number: 3362817
• Product Code: LRY
• UDI-Device Identifier: 04038653436811
• UDI-Public: 4038653436811
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021
• Report Date (Section F): 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FK961B
• Device Catalogue Number: FK961B
• Device Lot Number: 4510458720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 05/20/2021