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

Model Number	3003-009
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed us on february 15 that one of our products was involved in a procedure (posterior cranial fusion) resulting in a slippage, in which the treated patient sustained two lacerations.
Additional Manufacturer Narrative
The investigation of the product that was involved in the reported incident according to customer information has not yet been completed.The results of the product investigation and any further findings in connection with the described incident will be presented in a follow-up report.
Additional Manufacturer Narrative
The investigation of the product which, according to the customer, was involved in the reported incident had not yet been completed at the time of the initial reporting.This report presents the results of the product investigation.After careful inspection of the rejected product, it was found that the device shows no deviations or other abnormalities with regard to functionality and/or safety.As the device did not show any deviation that could cause 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.".

• Brand Name: DORO® QR3 SKULL CLAMP TEFLON
• Common Device Name: DORO® QR3 SKULL CLAMP TEFLON
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 18873065
• Report Number: 3003923579-2024-00003
• Device Sequence Number: 19585410
• Product Code: HBL
• UDI-Device Identifier: 04250435500781
• UDI-Public: 04250435500781
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 02/15/2024
• Report Date (Section F): 02/15/2024

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: 3003-009
• Device Catalogue Number: 3003-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Distributor Facility Aware Date: 02/15/2024
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/19/2024
• 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