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

Model Number 1001.001

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

The product was sent in for inspection in combination with a third-party torque screw.A clamping force inspection is not possible with the third-party component.Any risks arising from the use of a third-party component, in particular the torque screw, cannot be excluded nor assessed.The permissible components that can be combined with the product are specified in the instructions for use of the product.The second deviation, the slight play in the arch holder cannot have contributed to a slippage and has therefore no casual link to described incident.The maintenance interval was exceeded by the customer by 5 months.Any deviations detected could not have gone undetected during routine inspection and maintenance.The maintenance interval of one year is specified as mandatory in the product's instructions for use.No causal link can be established between the skull clamp sent in and the slippage described.In our experience, the pinning technique is decisive for the stability of the fixation of the patient's skull.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.".

Event Description

Customer informed us on february 22 that one of our products was involved in a procedure (suboccipital craniotomy) in which the patient sustained a laceration.

• Brand Name: DORO® QR3 SKULL CLAMP
• Type of Device: DORO® QR3 SKULL CLAMP
• 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: 18950458
• MDR Text Key: 338252765
• Report Number: 3003923584-2024-00005
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191740
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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