MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP; DORO® QR3 SKULL CLAMP TEFLON

Model Number	3003-009
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed our sales department on january 8 that one of our products was involved in a procedure in which the patient sustained a laceration.
Additional Manufacturer Narrative
The deviations identified during this investigation (worn threaded inserts at both the interface to the swivel adapter and the interface to the torque screw) are not to be considered as causative factors for the reported incident, as these errors could not have led to slippage of the patient's head in the skull clamp.The maintenance cycle for the product was exceeded by the customer by 5 months.The deviations found within this investigation could not have remained undetected or unremedied as part of the annual routine inspection and maintenance prescribed in the product's instructions for use.As no deviation that could have caused or contributed to the described incident was found during this investigation, we suspect that maybe the pinning technique has been 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.".

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® QR3 SKULL CLAMP TEFLON
• 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: 21155729
• Report Number: 3003923584-2025-00001
• Device Sequence Number: 8419528
• Product Code: HBL
• UDI-Device Identifier: 04250435500781
• UDI-Public: 04250435500781
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Administrator/Supervisor
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: 3003-009
• Device Catalogue Number: 3003-009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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