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

Model Number 1001.001

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

The device was inspected and tested on 10th may 2019.Within this inspection functional testing and visual inspection was made.Results: torque screw of a competitor was used with the clamp.Clamping pressure torque screw (competitor) was too low.Helicoil was turned out of the adjustable arm.Due to the use of a part, of a competitor, within the device we can not ensure the secure use of the skull clamp.The malfunction of the helicoil might have been caused by the third party device.However it can be excluded that the malfunction of the helicoil caused an increased pressure on the pin.As the competitors torque screw pressure was too low we suspect, that the pinning area of the skull had a precondition and that the pins were applied with too much pressure.

Event Description

Sales was contacted by distributor on (b)(6) 2019.Distributor stated that they were informed about a case in which pins went to far into the skull of a patient.There was no fracture but a leakage of liquor.

• Brand Name: DORO® SKULL CLAMP
• Type of Device: DORO® SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 8669630
• MDR Text Key: 148427124
• Report Number: 3003923584-2019-00012
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: (01)04250435506196
• Combination Product (y/n): N
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1