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

Model Number	1001.001
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed us on january 14 that one of our products was involved in an incident that resulted in a laceration.
Additional Manufacturer Narrative
The investigation carried out in this case did not reveal any deviations from the specification.However, with the clamp not lubricated (non-use scenario), a "tooth-on-tooth" position could be reproduced under correspondingly extreme conditions, which, however, could not go undetected based on the safety check specified in the product instructions for use after skull fixation.This condition may occur if the unlubricated or insufficiently lubricated arms of the product become jammed after clamping the patient's skull.This unfavorable condition can be detected by checking the quick-release button on the underside of the fixed arm of the skull clamp, as it does not lie (completely) flat against the underside in such a tooth-to-tooth position.Based on the description of the incident, it cannot be excluded that this condition was the cause of the subsequent slippage (jamming of the tilted arm's teeth).In the context of this complaint correspondence, the customer is advised of the relevant ifu specifications regarding proper lubrication and relevant safety checks.Furthermore, from our experience, pinning technique plays a significant role in slippage during skull fixation, so it cannot be excluded that the pinning of the patient's skull may not have been optimal as described in the instruction manual: "adjust the skull clamp to the width of the patient's head in the manner that the two skull pins in the rocker arm are equidistant from the centerline of the head and the single skull pin at the extension assembly is in line with this centerline.".

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® QR3 SKULL CLAMP
• Manufacturer (Section D): BLACK FOREST MEDICAL GMBH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 24332795
• Report Number: 3003923579-2026-00004
• Device Sequence Number: 17398034
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 02/13/2026
• Report Date (Section F): 01/14/2026

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: 1001.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Distributor Facility Aware Date: 01/14/2026
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• 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: Other
• Patient Sex: Unknown