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	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed us on march 11 that one of our products was involved in a case (posterior cervical) in which the treated patient sustained a laceration.
Additional Manufacturer Narrative
The rough-functioning locking wheel of the skull clamp's open-lock mechanism cannot have contributed to the incident described by the customer.The slight crack on the quick-rail of the skull clamp is a typical sign of improper handling (e.G.Dropping the product), although it cannot have contributed to the incident described.All other features of the product sent in comply with the specification and do not exhibit any defects in terms of functionality and safety.As it is not assumed that the detected deviation has contributed to the described incident (patient slipped while pinned), no causal link can be established between the slippage and the skull clamp sent in.In our experience, the pinning technique when clamping the patient head is decisive in relation to the prevention of slippages.Our recommendations in regards to the pinning technique is described in the product's 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.".

• 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
• MDR Report Key: 18967679
• Report Number: 3003923579-2024-00009
• Device Sequence Number: 20506722
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/11/2024
• Report Date (Section F): 03/11/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/11/2024
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown