MAUDE Adverse Event Report: Aesculap Inc. NOIR; PUNCH, SURGICAL

Model Number	FK961B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a kerrison detach 130dg up 200mm 1mm thin (part # fk961b) was used during a procedure on (b)(6) 2026.Reportedly the tip of the device broke inside the patient during surgery.The staff was able to remove the broken piece and went through their hospital policies to make sure it had all been removed from the patient this report is filed under or aic reference (b)(4).

• Brand Name: NOIR
• Common Device Name: PUNCH, SURGICAL
• Manufacturer (Section D): Aesculap Inc.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 50853436
• Report Number: 2916714-2026-00028
• Device Sequence Number: 18630267
• Product Code: LRY
• UDI-Device Identifier: 04038653436811
• UDI-Public: (01)04038653436811
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/22/2026