MAUDE Adverse Event Report: AESCULAP AG FW213R; S4 INSTRUMENTS

Model Number FW213R

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).When inserting the screw st274t by driver fw213r, the working end of the driver did not fit properly.Although the customer kept screwing, the screw head was deformed and the driver was not able to use.The screw was removed by other driver and new screw was used.Regarding sw790t set screw, torque function did not work.Therefore, the customer removed the set screw and confirmed the breakage.The fragments were removed.The procedure was done by using new one.

Manufacturer Narrative

Investigation: used test and analysis equipment: keyence vhx 5000 digital microscope.Panasonic dmc tz8 digital camera.Because the complainted screwdriver was not enclosed, we investigated the inner hexagon of the pedicle screw.Here we found that the inner hexagon was completely deformed.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: without further knowledge about the circumstances, we assume that the surgeon used a damaged screwdriver with an improper hexagon.A damaged hex tip usually causes damages to those observed in this case.No capa is necessary.

• Brand Name: FW213R
• Type of Device: S4 INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7652379
• MDR Text Key: 112861841
• Report Number: 9610612-2018-00262
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FW213R
• Device Catalogue Number: FW213R
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/11/2018
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other