MAUDE Adverse Event Report: PROMED INSTRUMENTS GMBH DORO (R) TEFLON SKULL CLAMP; HEADHOLDER

Model Number 3003-009

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Laceration(s) (1946)

Event Date 12/12/2012

Event Type  malfunction  

Event Description

The customer reported on (b)(6) 2012 that there was a pt slippage on (b)(6) 2012 with laceration but no serious pt injury occurred.Surgery was completed.Pt positioning: prone."dr stated he checked for lock 3 times, when placed on pt it slipped and lacerated at left anterior scalp approx 5 cm laceration." the device was received at pmi for inspection on (b)(6) 2013.

Manufacturer Narrative

Root cause: device was not regularly inspected as part of the annual inspection program.Index knob evaluated and alleged slippage failure could not be duplicated.Index knob was stiff due to possible debris/residue.Pin pressure testing showed a deviation which was minimal.This did not contribute to the event.Suspected root cause: wrong pinning technique.Corrective action: instructed customer to properly position the pt's head.Ensure that the 2 skull pins in the rocker arm are equidistant from the centerline of the head and that all 3 pins are penetrating the skull equally.The angle of the pins should be as close to 90 degrees possible to the pt's skull.Test that the skull clamp ext.Arm is fully engaged in the clamp base.Lock the index knob so that the arrow and "lock" are aligned.See instruction manual, device was repaired and can be used as intended.Returned product and another copy of the instruction manual to customer.

• Brand Name: DORO (R) TEFLON SKULL CLAMP
• Type of Device: HEADHOLDER
• Manufacturer (Section D): PROMED INSTRUMENTS GMBH; boetzinger strasse 38; freiburg 7911 1; GM 79111
• Manufacturer Contact: lutz babilon ; boetzinger strasse 38; freiburg 79111 ; GM 79111 ; 6138422242
• MDR Report Key: 4249930
• MDR Text Key: 5013031
• Report Number: 3003923584-2014-00008
• Device Sequence Number: 1
• Product Code: HBL
• 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: Foreign,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3003-009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/02/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• 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 Age: 58 YR
• Patient Weight: 77