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

Model Number 3003-009

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The slight deviation of the clamping pressure of the torque screw may have been detected during the annual maintenance, but the product has not been sent in for the annual service for more than the last two and a half years.However, it is not assumed that this slight deviation (< 1%) of the clamping pressure was causative for the described incident.This product was combined with third-party skull pins.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.The interval of the supplier maintenance was exceeded by two years and eight months by the customer.It cannot be excluded in general that any deviations may remain hidden if this maintenance specification is not complied with, and that possible risks may therefore arise.As it is not assumed that the detected deviation has caused the reported incident, 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.".

Event Description

Customer informed our sales department on the 26th of july that one of our products was invovled in a case where the patient slipped during patient positioning and a laceration occurred.

• Brand Name: DORO® QR3 SKULL CLAMP TEFLON
• Type of Device: DORO® QR3 SKULL CLAMP TEFLON
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 17622123
• MDR Text Key: 321917790
• Report Number: 3003923579-2023-00021
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435500781
• UDI-Public: 04250435500781
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2023

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
• Device Operator: Health Professional
• Device Model Number: 3003-009
• Device Catalogue Number: 3003-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other