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 Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

The investigation of the product that was involved in the reported incident according to customer information has not yet been completed.The results of the product investigation and any further findings in connection with the described incident will be presented in a follow-up report.

Event Description

Customer informed us on february 15 that one of our products was involved in a procedure (posterior cranial fusion) resulting in a slippage, in which the treated patient sustained two lacerations.

Manufacturer Narrative

The investigation of the product which, according to the customer, was involved in the reported incident had not yet been completed at the time of the initial reporting.This report presents the results of the product investigation, which is why the following fields have been added or corrected since the initial report: b6, c, g6, h2, h3, h6, h11.After careful inspection of the rejected product, it was found that the device shows no deviations or other abnormalities with regard to functionality and/or safety.As the device did not show any deviation that could cause 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.".

• 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
• 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: 18873067
• MDR Text Key: 337290050
• Report Number: 3003923584-2024-00003
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435500781
• UDI-Public: 04250435500781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001808
• 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,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 02/26/2024
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• 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