MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 APPLYING FORCEPS NON-DETACH; INSTR./ACCESS. FOR CRANIOFIX 2 IMPL

Model Number FF494R

Device Problems Disassembly (1168); Mechanical Problem (1384)

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6)."while insertion it was impossible to disassemble the plate.It caused bleedings at the patient." the user presumes a defect on the inner rod system although the instrument is nearly new.

Manufacturer Narrative

Investigation: used test and analysis equipment: keyence vhx 600d digital microscope.Panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.Here we found a gap between the screw sleeve and the instrument body.Root cause was a broken fixation.So the sleeve screw became loose during operating the instrument.Conclusion and root cause: the root cause is most probably manufacturing related.No capa is necessary.

• Brand Name: CRANIOFIX 2 APPLYING FORCEPS NON-DETACH
• Type of Device: INSTR./ACCESS. FOR CRANIOFIX 2 IMPL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7305786
• MDR Text Key: 101347479
• Report Number: 9610612-2018-00086
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• 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: 01/31/2018
• Distributor Facility Aware Date: 02/16/2018
• Date Manufacturer Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other