MAUDE Adverse Event Report: MEDICON EG MEDICON; KERRISON STZ DIEBLAUEN 20CM 3MM 40° OB SCHM STANZPL AW

Model Number	57.28.33
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was reported to the manufacturer through the fda medsun program (report no.(b)(4).As of the date of this report, the manufacturer has not received the involved device for evaluation.Furthermore, no additional information beyond the initial report has been provided.The manufacturer has made multiple attempts to obtain further details and the return of the device; however, no response has been received to date.Therefore, a thorough investigation could not yet be performed.The manufacturer will continue efforts to obtain the device and additional information.A follow-up report will be submitted if and when further relevant information becomes available.
Event or Problem Description
Describe the event or problem: from staff: while performing part of the patient's spinal surgery, the tip of the instrument being used (spikeless kerrison 3) broke off.No evident harm occurred; the broken piece of the instrument was easily recovered from the patient.What was the original intended procedure? t11 through l4 instrumented posterior spinal fusion with navigation.L2 laminectomy for decompression of spinal cord.Use of neuro monitoring.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working); device malfunction - that is, the device did not do what it was supposed to do.Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not known.

• Brand Name: MEDICON
• Common Device Name: KERRISON STZ DIEBLAUEN 20CM 3MM 40° OB SCHM STANZPL AW
• Manufacturer (Section D): MEDICON EG; gaensaecker 15; tuttlingen, baden-württemberg 78532 ; GM 78532
• Manufacturer Contact: peter grossmann ; gaensaecker 15; tuttlingen, baden-württemberg 78532 ; GM 78532
• MDR Report Key: 24938171
• Report Number: 8010099-2026-00001
• Device Sequence Number: 17438401
• Product Code: HTX
• UDI-Device Identifier: 04046826404338
• UDI-Public: (01)04046826404338
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 57.28.33
• Device Catalogue Number: 57.28.33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 56 KG