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

Model Number 3034-00

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 01/25/2024

Event Type  Injury  

Event Description

Customer informed us on (b)(6) that one of our products was involved in a procedure (posterior cranial fusion, prone position) in which the treated patient sustained a superficial laceration.

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
• Type of Device: 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: 18756245
• MDR Text Key: 335934983
• Report Number: 3003923584-2024-00002
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other