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	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed us on january 31 that one of our products was involved in a procedure (posterior cranial fusion, prone position) in which the treated patient sustained a superficial laceration.
Additional Manufacturer Narrative
As it was discovered during the investigation that the release button of the skull clamp was broken, the customer was contacted to ask whether he had noticed this deviation during use or before complaining about the product, as he did not mention the defect in the description of the complaint.The customer stated that he had not noticed any abnormalities with regard to the safety or functionality of the product since the last manufacturer service.As it is very unlikely that the breakage of the skull clamp's release knob went undetected by the customer, it is assumed that the breakage was caused by an external impact (lateral force) during transportation of the skull clamp to the manufacturer's service unit.It is therefore not assumed that the deviation existed at the time of the incident (slippage) or could have contributed to the incident.We suspect that maybe the pinning technique has not been 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.".

• 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: 18756244
• Report Number: 3003923579-2024-00002
• Device Sequence Number: 11697561
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2024
• Report Date (Section F): 01/31/2024

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: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/31/2024
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2024
• 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