MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 11MM; CRANIAL CLOSUREGXN

Model Number FF490T

Device Problems Material Separation (1562); Separation Problem (4043)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that the device was broken during surgery.Clamp and pin were separated.The device was replaced by a new one and caused a surgery delay of 10 to 15 minutes.There was no patient harm.There was no additional information provided.

Manufacturer Narrative

Investigation results: the implant arrived detached with cut off pin.Investigation was carried out microscopically.Here we found, that the pin was cut underneath the latch that has fixed the upper disc.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There is no further complaint with this lot at hand.The root cause for the problem is most probably usage related.The pin was cut off underneath the latch that has fixed the upper disc.The wear on the first latch underneath the cutting edge is a sure hint that the spring segment of the upper disc was not driven completely over the next latch.A capa was not initiated.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 11MM
• Type of Device: CRANIAL CLOSUREGXN
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8831591
• MDR Text Key: 152351938
• Report Number: 9610612-2019-00519
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF490T
• Device Catalogue Number: FF490T
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention