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

Model Number	3003-009
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor informed us on april 15 that one of our products was involved in a procedure resulting in a slippage, in which the treated patient sustained a laceration.
Additional Manufacturer Narrative
It cannot be assumed that any of the deviations found on the skull clamp could have contributed to the incident described by the distributor.The play in the openlock mechanism only occurs in the open position and is due to wear.The deviation of the worn threaded inserts of the skull clamp is also due to wear, i.E.A result of frequent use and/or insufficient lubrication, which is mandatory according to the product's instructions for use the identified deviations could not have gone undetected by the manufacturer as part of the mandatory annual routine inspection interval specified in the product's instructions for use.However, this service interval for the product was exceeded by 11 months by the customer.The skull pins sent in with the product were also not serviced properly/as specified in the ifu.All three skull pins have not been sent to the manufacturer for maintenance for at least 6 years and show corresponding signs of wear on their tips (blunted).It cannot be ruled out that the worn skull pins could have contributed to the event described, but it is unlikely that they were the sole cause of the incident.However, this deviation could not have gone undetected during regular routine inspection and maintenance by the manufacturer.The customer will be informed by the instructions for use of the product as well as in the course of the processing of the of the present complaint(s).After careful inspection of the product, no causal link to the event described can be established.Therefore 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
• 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: 19297105
• Report Number: 3003923584-2024-00016
• Device Sequence Number: 20297451
• Product Code: HBL
• UDI-Device Identifier: 04250435500781
• UDI-Public: 04250435500781
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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: 04/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown