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

Model Number 1001.001

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  Injury  

Manufacturer Narrative

The customer has not yet sent in the product for investigation.A follow-up report will be submitted as soon as the product has arrived and the findings have been completed.

Event Description

Distributor informed us on the 7th of august that one of our products was involved in a procedure in which the patient's head fell out of the skull clamp, causing the surgery to abort.

Event Description

Distributor informed us on (b)(6) that one of our products was involved in a procedure in which the patient's head may get fallen down from the clamping device because the skull clamp lost pressure, causing the surgery to abort.

Manufacturer Narrative

Since the rejected product was not yet available for examination at the time of the initial reporting, the results of the examination and the resulting findings with regard to the cause of the incident described are presented in this report.The event description has been corrected according to the feedback provided by the customer.The product does not show any deviations from the specification.The skull clamp was tested in both unlubricated and lubricated condition.In the usage scenario (relevant features of the cranial clamp lubricated as specified in ifu), no malfunction or other abnormality can be detected in the product.In unlubricated condition, a canting of the extension arm and the fixed arm of the skull clamp is possible, which can lead to a subsequent slipping of the teeth and a resulting drop in pressure of the torque screw, as described by the customer.It is therefore assumed that the clamp was not or not sufficiently lubricated by the user.The detailed specifications for maintenance and care (cleaning, lubrication, servicing) of the product are mandatory in the associated ifu.No injuries were reported as a result of this incident, but as the operation had to be postponed due to the described incident, we decided to report this case.

• 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: 17689047
• MDR Text Key: 322698991
• Report Number: 3003923584-2023-00024
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other