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 Date 10/30/2023

Event Type  Injury  

Event Description

Customer informed us on (b)(6) that one of our products was involved in a case (posterior c3-t1 fusion in prone position), in which the treated patient sustained a laceration.

Manufacturer Narrative

The serial number (b)(6) originally stated by the complaining user on the returned goods form did not match the serial number of the product actually sent in, whereupon the discrepancy was raised with the reporting user.Upon request, the reporting user was unable to identify the actual product involved in the incident, which is why the product originally reported but not yet sent in is subsequently sent to the manufacturer's site for inspection.The corresponding investigation results will be supplemented in a follow-up report.It is not assumed that the deviations found on the skull clamp sent in could have contributed to the incident described by the customer ("slipped on the rocker arm side of headrest during a posterior cervical fusion").The product passed all functional test steps despite two features failed the visual inspection.The old version of the pin insertion and the worn teeth on the skull clamp's starburst interface cannot have contributed to the reported slippage.Although the teeth of the product's extension arm (sliding component) were visibly damaged (broken off at some points), this damage did not affect the sliding behavior of the skull clamp in this case.The maintenance interval specified for the product was exceeded by the customer by 1 year and 11 months.The deviations found could not have remained undetected if the product had been sent in according to the specifications.The customer is advised to observe the maintenance interval in accordance with the instructions for use.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.".

Manufacturer Narrative

As the customer informing us of the incident could not say with certainty which of the two skull clamps in question (serial no.(b)(6)) was involved in the incident, both products were examined under consideration of the given incident description.The examination results for the first skull clamp in question (serial no.(b)(6)) were presented in the initial report.After receipt and examination of the second skull clamp (serial no.(b)(6)), this follow-up report was created.No deviations were found during this inspection.Therefore, no causal connection between the product and the event described can be established for this skull clamp either.The maintenance interval was also not observed for this skull clamp (exceeded by 2 years).Any deviations may remain undetected if the maintenance interval is not observed.The customer is advised to observe the maintenance interval in accordance with the product's instructions for use.It is not possible to determine with certainty which of the two skull clamps sent in was actually involved in the incident.Since none of the products showed any deviations that could have been the cause of the described 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." in this follow-up report, the fields b6, f7, f9 have been supplemented and/or corrected.

• 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: 18309441
• MDR Text Key: 330226817
• Report Number: 3003923579-2023-00029
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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
• Distributor Facility Aware Date: 11/20/2023
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other