MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® QR3 SKULL CLAMP TEFLON

Model Number 3003-009

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

The customer informed us on january 24 that one of our products was involved in a procedure in which the patient being treated sustained an injury.The responsible sales representative informed us that he believed the occurred injury was a laceration.No further information was provided despite follow-up requests.

Manufacturer Narrative

The deviation found on the skull clamp sent in (clamping force of the torque screw slightly above the specification) and the outdated pin insertion cannot have contributed to the event described by the customer (slippage).Therefore, no causal link can be established between the device and the reported incident.The maintenance interval of one year specified in the product's instructions for use was exceeded by the customer by 2 years and 8 months.The findings on the device described in this report could not have gone undetected during such a routine inspection.As none of the deviations found in this inspection are assumed to have contributed to the reported incident, we suspect, that maybe the pinning technique has been 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." information relevant to this report (skull pins used, date of incident, clamping force applied, etc.) was not provided despite repeated queries by the manufacturer to the reporting parties.If new information or findings are received, these will be subsequently submitted in a follow-up report.

• Brand Name: DORO® QR3 SKULL CLAMP TEFLON
• Type of Device: DORO® QR3 SKULL CLAMP TEFLON
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 18748363
• MDR Text Key: 335880827
• Report Number: 3003923579-2024-00001
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Model Number: 3003-009
• Device Catalogue Number: 3003-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/24/2024
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other