MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP; DORO® MULTI-PURPOSE SKULL CLAMP

Model Number	3020-50
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No injury was reported, but as there was a potential risk reported ("skull clamp opened") we decided to report this case.The device was inspected and tested.Within this inspection functional testing and visual inspection was made.It is very unlikely that the detected deviations have contributed to the reported event - "mutli purpose clamp had opened"- 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.".
Event or Problem Description
During operation procedure with neuronavigation multi purpose clamp had opened.Continuation of the operation with neuronavigation not possible.Operation was completed by neurosurgeon assistant holding children head in hand.Medical incident was declared.
Additional Manufacturer Narrative
Additional information received on december 12th 2017.This information gave us a clearer picture of the situation.The reporter informed us, that the release knop was incidently opened.
Event or Problem Description
Additionally information received on december 12th 2017: the clamp was incidently opened, during the surgery someone reached the knob of the release knob of the skull clamp, which opened the skull clamp.The risk was being seen in the head being able to fall down to the metal parts of the skull clamp.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® MULTI-PURPOSE SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 7057672
• Report Number: 3003923584-2017-00047
• Device Sequence Number: 1895876
• Product Code: HBL
• UDI-Device Identifier: 04250435501689
• UDI-Public: (01)04250435501689
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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
• Operator of Device: No Information
• Device Model Number: 3020-50
• Device Catalogue Number: 3020-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/24/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Weight: 217