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

Model Number 3034-00

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

The deviations found on the skull clamp sent in cannot have contributed to the event described by the customer.The identified deviations (worn thread and crack in the product's quick-rail) are handling-related errors, but do not represent any restrictions with regard to the safety and/or effectiveness of the product.All other features of the device in question comply with the specification and do not exhibit any defects in terms of functionality and safety.Due to the nature of the found deviations, no causal link can be established between the slippage and the skull clamp sent in.Since this examination did not reveal any deviations in the skull clamp that could have contributed to the event described (slipping of the head out of the clamp), we suspect that the pinning of the patient's head 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.".

Event Description

Customer informed us on march 1 that one of our products was involved in a procedure (craniotomy for aneurysm) in which the treated patient sustained a laceration.

• Brand Name: DORO® SKULL CLAMP RADIOLUCENT
• Type of Device: 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: 18991168
• MDR Text Key: 338889208
• Report Number: 3003923584-2024-00008
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3034-00
• Device Catalogue Number: 3034-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other