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

Model Number	3020-50
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed us on the (b)(6) that one of our products was involved in a procedure (4 pin configuration) in which a laceration occured to the patient.
Additional Manufacturer Narrative
The customer has not yet sent in the product for investigation.The customer was fairly confident that this was user error due to the surgeon being unfamiliar with 4 pin fixation, so the device will not be to send in for inspection.We will perform a follow-up if the product arrives.
Additional Manufacturer Narrative
Udi related data quality updates only.The following information is being corrected/supplemented due to discrepancies between data submitted in the previous report(s) and data submitted to the gudid: d1, g6, h2.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® MULTI PURPOSE 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: 17918595
• Report Number: 3003923584-2023-00026
• Device Sequence Number: 15116756
• Product Code: HBL
• UDI-Device Identifier: 04250435501689
• UDI-Public: 04250435501689
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K001808
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 3020-50
• Device Catalogue Number: 3020-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2023
• 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