MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 20MM; CRANIOFIX 2 IMPLANTS

Model Number FF492T

Device Problem Break (1069)

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

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).During a surgical procedure the pin broke.

Manufacturer Narrative

Investigation: used test and analysis equipment; ;-keyence-vhx 600 d microscope; -panasonic dmc tz8 digital camera.We made a visual inspection of the cutting edges.The cutting edge of the pin on the lower disc exhibits the typical cut marks of a cutting instrument such as from a wire cutter.The pin leaving exhibits the same cut pattern.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause of the problem is most probably user related.Rational: the fixation pin of the lower disk was cut skewed and too short (underneath the last fixation rim).The impacts of the cutting edges are clearly visible at the pin and the pin leaving.The ifu contains clear hints for correct application and cutting.No capa is necessary.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 20MM
• Type of Device: CRANIOFIX 2 IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6575916
• MDR Text Key: 75463723
• Report Number: 9610612-2017-00249
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: FF492T
• Device Catalogue Number: FF492T
• Device Lot Number: 52287342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/09/2017
• Device Age: 6 MO
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other