MAUDE Adverse Event Report: AESCULAP AG AND CO, KG CRANIOFIX 2 TITANIUM CLAMP 16MM

Model Number FF491T

Device Problems Break (1069); Component Falling (1105)

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

Event Date 11/20/2013

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).When the surgeon tightened the product by using ff494r, part of upper disk was broken and fell down.This issue occurred before cutting the shaft.Fragment was retrieved.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2013.Manufacturing site evaluation: the upper disc and fragment were analyzed.The upper disc displays plastic deformations and the pin slightly bent.At the part where the pin is bent most heavily, there are damages visible on the pin indentation.Review of manufacturing documents for batch (b)(4) indicate quality records and production documents comply with oem specification and do not present any discrepancies.No other similar incidents have been declared regarding this batch number.A material or manufacturing defect could not be found.There is evidence that the heavy plastic deformation was caused due to high force which is not expected on the intended use.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 16MM
• Manufacturer (Section D): AESCULAP AG AND CO, KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG AND 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: 3908035
• MDR Text Key: 4665963
• Report Number: 3005673311-2014-00006
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: FF491T
• Device Catalogue Number: FF491T
• Device Lot Number: 51932316
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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