MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 APPLYING FORCEPS NON-DETACH; CRANIAL IMPLANTS

Model Number FF494R

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "the surgeon reports that the closing system applicator clamp attachment in placing the craneofix implant does not make the correct tightening, leaving the implant without sufficient force." there was a 15 minute delay in surgery when placing the third implant.

Manufacturer Narrative

Investigation: used test and analysis equipment: keyence vhx-5000 digital microscope.Panasonic dmc tz8 digital camera.Mecmesin afg 500n force measuring device.For investigation we sent the instrument to our technical service department.There they tested the clamping function and the pulling force of the device.The clamping function worked well.All measured values are within the specification between 280 newtons and 350 newtons.Conclusion and root cause: the root cause of the problem is most probably usage related.Rationale: we tested the function and the force values of the instrument and found it according to the specification.Without further knowledge about the circumstances, we assume a handling error (not correctly attached to the pin) or a bent/defective pin.No capa is necessary.

• Brand Name: CRANIOFIX 2 APPLYING FORCEPS NON-DETACH
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8392169
• MDR Text Key: 137879122
• Report Number: 9610612-2019-00161
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: FF494R
• Device Catalogue Number: FF494R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Distributor Facility Aware Date: 03/13/2019
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other