MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP; 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	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor informed us on january 27 that one of our products was involved in a case in which a laceration occured.
Additional Manufacturer Narrative
It is not assumed that the deviation (measured pin force of the device's torque screw below specification) found within this investigation did contribute to the incident described.As the customer explicitly reported a loss of pin force of the skull clamp's torque screw ("[.] we tried to tighten the mayfield we would tighten it down to 80 pounds of pressure and then position her and then when we would go back and check the pressure on the mayfield head holder it would be reduced in half.We increased the pressure twice and this happened twice more where the mayfield released the pressure that we had applied to it.The screws were obviously not firmly planted into the patient's skull."), this feature of the device in particular was carefully inspected.The torque screw in question was subjected to a "creep test', i.E.A pin force measurement over time.In this test procedure, the torque screw of the device was fed into a clamping force measuring device over several hours (>8h) in order to check for any loss of force using the pin force indicator on the torque screw.No change in clamping force could be detected using the clamping force indicator as described by the customer.As no causal link could be established between the device sent in and the incident described, it cannot be excluded that the pinning technique in this case was not optimal, as described in the 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." additional information on this incident was requested.Any new information or findings will be presented in a follow-up report upon receipt.

• Brand Name: DORO® SKULL CLAMP
• 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: 21433780
• Report Number: 3003923579-2025-00005
• Device Sequence Number: 4618239
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/27/2025
• Report Date (Section F): 01/27/2025

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: 02/10/2025
• Distributor Facility Aware Date: 01/27/2025
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2025
• 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