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

Model Number FF491T

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that when installing the craniofix: (tightening and cutting) of the rod according to the instructions; the rod/stem and the upper part of the device loosened.

Manufacturer Narrative

Investigation: used test and analysis equipment: microscope "keyence- vhx 5000" a visual inspection was performed.It was clearly visible, that the pin of the lower disk was cut too short near the disc, the last catch is completely cut off.So a fixation of the clap is not possible and the upper disc came off.Batch history review: the manufacturing documents have been checked and found to be according to specification which was valid during the time of production.Conclusion and root cause: the root cause for the problem is user related.Rational: usually, if the diameter of the hole is correct, it is not possible to get the discs so close together that it is possible to cut so low, or the bone was to thin for using this system corrective action: according to (b)(4) there is no capa necessary.

• 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: 6126378
• MDR Text Key: 60877904
• Report Number: 2916714-2016-00980
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: FF491T
• Device Catalogue Number: FF491T
• Device Lot Number: 52265379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/09/2016
• Device Age: 2 MO
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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