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

Model Number	3034-00
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The slight deviation (<10%) of the pressure reading cannot be the cause of the slippage.Since the surface of the product has different types of damages (scratches and impact / pressure marks) in several points, we assume that the general condition of the product is conditioned by improper handling by the customer.It is also suspected that the crack in the fixed arm at the interface with the extension arm was caused by external impact(s).In general, it cannot be excluded that further of the detected deviations, such as that of the clamping screw, were caused by improper handling of the device and/or by external impacts of force.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.
Event or Problem Description
Customer informed our service department on the 24th of february that one of our products was involved in a case where a laceration occured.

• Brand Name: DORO® SKULL CLAMP RADIOLUCENT
• Common Device Name: DORO® SKULL CLAMP RADIOLUCENT
• 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: 16599806
• Report Number: 3003923584-2023-00009
• Device Sequence Number: 6165228
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 4250435502181
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: 3034-00
• Device Catalogue Number: 3034-00
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown