MAUDE Adverse Event Report: AESCULAP AG AND CO. KG CRANIOFIX 2 TITANIUM CLAMP 16MM; FIXATION PLATE

Model Number FF491T

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/29/2014

Event Type  No Answer Provided  

Event Description

Country of complaint: brazil.During closing procedure of skull, the device dropped.

Manufacturer Narrative

U.S.Reporting agent notified on: 03/23/2015.Manufacturing site evaluation: visual inspection: the lower disc with the rest of the pin and the upper disc arrived in a decontaminated condition.Microscopic inspection: under the microscope it is clearly visible, that the pin was cut skew and with a blunt or improper tool.Conclusion: it is visible, that a pin of the clamp was cut with a blunt or improper tool.During cutting with this, the fixation groove was damaged and the disc came off.Both the pin being cut skew or with improper tool are related to human error.The manufacturing documents have checked and found to be according to specification during the time of production.There are currently no other complaints of lot.52022097.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 16MM
• Type of Device: FIXATION PLATE
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen DE 78532
• Manufacturer (Section G): AESCULAP AG AND CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4664917
• MDR Text Key: 5730426
• Report Number: 2916714-2015-00275
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: FF491T
• Device Catalogue Number: FF491T
• Device Lot Number: 52022097
• Date Manufacturer Received: 07/30/2014
• Date Device Manufactured: 03/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1