MAUDE Adverse Event Report: BLACK FOREST MEDICAL GMBH DORO® SKULL CLAMP; DORO® QR3 MULTI PURPOSE SKULL CLAMP

Model Number	3020-50
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reporting customer provided video footage, which, upon review, showed that the two-pin-holder adapter plate exhibited rotational movement.The rocker arm appears rigid in the video and shows no rotational movement, which indicates proper fixation of the openlock mechanism.Upon receipt of the device in question and the associated accessories (two-pin-holder adapter plate), the device was tested in the configuration shown in the video provided (reportedly used when the laceration occurred).Rotational movement of two-pin-holder adapter plate corresponding to the provided video footage was found to be only possible when the receptacle (clamping mechanism) for attachment of the two-pin-holder adapter plate is not locked or inadequately locked.No deviations were found on the device.At the time of this report, the customer has been informed of the investigation results and the corresponding instructions regarding proper installation of the device and safety checks prior to clinical use as part of the complaint correspondence.Further information has been requested.Any new findings regarding this incident may be included in a follow-up report upon receipt.
Event or Problem Description
Customer informed us that one of our products was involved in a case in which the patient sustained a laceration.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® QR3 MULTI PURPOSE SKULL CLAMP
• Manufacturer (Section D): BLACK FOREST MEDICAL GMBH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): BLACK FOREST MEDICAL GMBH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: nicholas preissler ; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 24647294
• Report Number: 3003923584-2026-00008
• Device Sequence Number: 9796813
• Product Code: HBL
• UDI-Device Identifier: 04250435501689
• UDI-Public: 04250435501689
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3020-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2017
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown