MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP; DORO® SKULL CLAMP RADIOLUCENT

Model Number	3034-00
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the customer explicitly reported a failure of the openlock mechanism of the skull clamp ("locking mechanism failed resulting in the dual pin holder on the c-clamp to come loose dropping the patients head"), this feature of the device in particular was carefully inspected.No deviations could be identified in the feature affected according to the customer feedback.The mechanism in question is fully functional.It is not assumed that the deviation (measured pin force of the device's torque screw below specification) found within this investigation did contribute to the incident described.As no causal link could be established between the device sent in and the incident described, it cannot be excluded that the pinning technique in this case was not 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." we recommend using our skull pins in combination with our skull clamps.Risks due to not permitted system combinations with third party components could not be excluded, as in this case.Additional information on this incident was requested.Any new information or findings will be presented in a follow-up report upon receipt.
Event or Problem Description
Distributor informed us on january 27 that one of our products was involved in a case in which a laceration occured.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® SKULL CLAMP RADIOLUCENT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: nicholas preissler ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 21433779
• Report Number: 3003923584-2025-00004
• Device Sequence Number: 4618238
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063494
• 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: Administrator/Supervisor
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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: 3034-00
• Device Catalogue Number: 3034-00
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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