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 02/12/2024

Event Type  Injury  

Event Description

Distributor informed us on march 18 that one of our products was involved in a procedure (suboccipital crani resection arteriovenous malformation) in which the treated patient sustained a laceration.

Manufacturer Narrative

The crack in the product's quick-rail is due to improper handling (e.G.Products dropped), although it does not represent any restrictions with regard to the safety and/or effectiveness of the product and cannot have contributed to the incident described by the customer.The measured clamping pressure values of the product's torque screw are below specification.The pressure measurement of the skull clamp must be checked regularly.The maintenance interval of one year specified in the instructions for use of the product was exceeded by the customer by 1 year and 4 months.The device was therefore not checked regularly as part of the annual maintenance program.A possible deviation in the clamping force of the product's torque screw or in other features of the product may remain undetected if the maintenance interval is not met.All other features of the appliance in question comply with the specification and do not exhibit any defects in terms of functionality and safety.The customer is advised of his obligations to comply with the maintenance interval and the associated periodic servicing to ensure the safety and effectiveness of the product.From our experience the pinning technique is decisive when it comes to slippages.It can not be excluded that in this case, the pinning technique has not 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 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: 18968588
• MDR Text Key: 338489592
• Report Number: 3003923584-2024-00010
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• 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: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• 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