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

Model Number 1001.001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skull Fracture (2077)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

As the device is in specification and 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." based on previous reports, we suspect that the patient's advanced age and possible pre-existing conditions may have contributed to the reported incident.

Event Description

Customer informed our service department on the 18th of march that one of our products was involved in a bilateral skull fracture.

• 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
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: christopher schmitz ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 11677149
• MDR Text Key: 245819100
• Report Number: 3003923584-2021-00008
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

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: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR