MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 16MM; CRANIAL IMPLANTS

Model Number FF491T

Device Problem Break (1069)

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

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that during surgery the pin broke when trying to fix the disk.

Manufacturer Narrative

Investigation: used test and analysis equipment; keyence-vhx 600 d microscope; (b)(4) digital camera.We made a visual inspection of the spring segments of the upper disc and the pin at the lower disc.Here we found, that the pin was cut skewed.Next we investigated the upper disc.We found that some of the spring segments were bent.Finally, we investigated the pin leaving.Again we found a skewed cutting edge and a damaged fixation rim.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 for the problem is most probably user related.Rational: some of the spring segments are bent, this is a clear hint for a handling error (upper disc applied slanted/handling with wrong instruments, etc).No capa is nesessary.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 16MM
• Type of Device: CRANIAL 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: 6181917
• MDR Text Key: 62684865
• Report Number: 2916714-2016-01012
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2021
• Device Model Number: FF491T
• Device Catalogue Number: FF491T
• Device Lot Number: 52250653
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/23/2016
• Device Age: 5 MO
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• 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