MAUDE Adverse Event Report: S.U.A. MARTIN GMBH & CO. KG V. MUELLER CLEANACCESS# KERRISON RONGEUR T-COAT MICRO HANDLE

Catalog Number	NL4291-81T / SAMV0110814ZBAT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Microscopic examination of the device showed that it had been subject to repair by an unauthorized third party.The cutting edge of the device had been ground, removing its protective coating, weakening the foot plate, and likely causing it to break during use.Notches on the cutting edge would have made clean cuts impossible and required increased force during use.The instrument was returned incomplete, i.E., without the broken-off tip.Material hardness was checked and found to be conforming to specifications.Review of manufacturing records revealed no nonconformance issues.
Event or Problem Description
During a laminectomy procedure, the tip of the kerrison rongeur broke and fell into the surgical field.It was retrieved with a bayonet forceps.The patient was fine and the procedure was completed as planned.

• Brand Name: V. MUELLER CLEANACCESS# KERRISON RONGEUR T-COAT MICRO HANDLE
• Common Device Name: KERRISON RONGEUR
• Manufacturer (Section D): S.U.A. MARTIN GMBH & CO. KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer (Section G): S.U.A. MARTIN GMBH & CO. KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer Contact: markus pauli ; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• MDR Report Key: 24265786
• Report Number: 8010386-2026-00001
• Device Sequence Number: 18656768
• Product Code: HAE
• UDI-Device Identifier: 10885403187537
• UDI-Public: 0110885403187537
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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 Catalogue Number: NL4291-81T / SAMV0110814ZBAT
• Device Lot Number: G21XME / 2190876
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown