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

Model Number 1001.001

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

The product allegedly involved in the reported incident has not yet been sent to the manufacturer for investigation.The product and additional information regarding the reported incident have been requested.As new information is received, it will be presented in a follow-up report.

Event Description

Health canada informed us on the (b)(6) that one of our products was involved in a case (cervical spine laminectomy, c4-5) where the patient being treated suffered a minor laceration, which had to be approximated with staples.

Manufacturer Narrative

Since the rejected product was not yet available for examination at the time of the initial reporting, the results of the examination and the resulting findings with regard to the cause of the incident described are presented in this report.As the product was in specification and did not show any deviations 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." the product was last sent to the manufacturer's us site for routine maintenance in february of this year.During the inspection at that time, the service department found that the extension arm of the skull clamp could not be fully inserted into the skull clamp's base.The deviation was remedied at that time by preventative measures (grinding off impact points or the distorted feature), inspection, functional check and lubrication.In this report, the contents of fields b6, d9, f7 and h10 have been supplemented or updated due to the receipt of the product by the manufacturer and the new findings regarding the product condition as well as possible correlations with the incident described.

• Brand Name: DORO® QR3 SKULL CLAMP
• Type of Device: DORO® QR3 SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 18063311
• MDR Text Key: 327241733
• Report Number: 3003923579-2023-00027
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 10/04/2023
• Device Age: 32 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other