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 07/31/2023

Event Type  Injury  

Manufacturer Narrative

The customer has not yet sent in the product for investigation.A follow-up report will be submitted to present the results of the inspection once the product has arrived and the investigation has been completed.

Event Description

Distributor informed us on the (b)(6) that one of our products was involved in a case (craniotomy) in which the treated patient sustained a laceration.

Manufacturer Narrative

In the previous initial report, the product had not yet arrived at the manufacturer for examination, as described.It is not assumed that the slight deviation of the tensioning pressure of the torque screw (<1%) could have contributed to the described incident.Therefore it is assumed 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." the interval of the supplier maintenance which is specified in the product's ifu was exceeded by 10 months by the customer.Due to this circumstance, we cannot exclude that the deviations found are the result of normal wear and tear and could have been detected during annual maintenance.

• 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: 17639577
• MDR Text Key: 322137057
• Report Number: 3003923584-2023-00022
• 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: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• 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 Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2021
• 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