MAUDE Adverse Event Report: AESCULAP AG & CO. KG CRANIOFIX 2 TITANIUM CLAMP 20MM

Model Number FF492T

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/28/2013

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Case of frontotemporal craniotomy; the disks were coming off.When the customer tried to close the cranial bone using this product, the disks of this product were coming off.Operation delayed over 15 minutes.Customer claims: handling and thickness of cranial bone were correct.Because the cranial bone was fixed properly at the same point using another ff492t.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: the craniofix has been analyzed macroscopically.It can be clearly seen that the pin has been cut off too short where there are no more anti-slip serrations.The cutting is also not perpendicular to the pin, but slightly sloped.The corresponding side of the craniofix exhibits damage to the fins where the two plates have been compressed prior to cutting.The pins are also not equally deformed.The cause for the loosening of the plate is that the pin has been cut too short.Root cause is user error.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 20MM
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 7853 2
• Manufacturer (Section G): AESCULAP AG & CO. KG; p.o. box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3883104
• MDR Text Key: 16176582
• Report Number: 2916714-2014-00102
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF492T
• Device Catalogue Number: FF492T
• Device Lot Number: 51947823
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/10/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other