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

Model Number 3034-00

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

No investigation possible.Product not received for evaluation.

Event Description

On 08/01/2017 and 08/04/2017 pmi was informed about the following event: description: "during patient positioning in the mayfield, one of the pins continuously slipped after multiple attempts to secure patient." injuries: multiple pin locations, head wounds; procedure being performed: pinning of patient in prone position; surgery completed: yes; date of incident: (b)(6) 2017.Further information was requested by pmi.

Manufacturer Narrative

We conducted the final inspection of the device on 6th september 2017.Result was: the device was out of specification.It generally cannot be excluded that the device has contributed to the event.However considering the minor deviations of the device, it is very unlikely that the device actually has contributed to this event.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 pin pressure deviation will be investigated at pmi internal.The impact on the use of brainlap skull pins, we can not evaluate, as they are not pmi products.As the device was out of specification, it cannot be excluded that the device has contributed to the reported incident.However from the information reported we suspect that the reported incident may be due to insufficient pin pressure and/or insufficient application of the skull clamp and placement of skull pins.

Event Description

This is follow-up 01.

• Brand Name: DORO® SKULL CLAMP RADIOLUCENT
• Type of Device: DORO® SKULL CLAMP RADIOLUCENT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 6833414
• MDR Text Key: 84071971
• Report Number: 3003923584-2017-00035
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: (01)04250435502181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

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: 3034-00
• Device Catalogue Number: 3034-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 01/08/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention