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 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: according to the available information there were no negative consequences for the patient.The pin cutter shows no outwardly defects.The clamp arrived in three parts, pin, upper disc and lower disc.Used test -and analysis: microscope, digital camera.A visual inspection of the lower disc, especially the pin and its cutting edge.The lower disc exhibits a pin which was cut skewed and underneath the last rims, so the disc must came off.Furthermore performed some cutting tests with the pin cutter.The pin cutter worked properly without any problems.The detached implant and the pin - cutter in their incoming condition.The manufacturing documents have checked and found to be according to specification valid during the time of production.The root cause for the problem is most probably usage related.The pin of the clamp was cut underneath the last fixation rim.A capa is not necessary.

Event Description

Country of complaint: (b)(6).It was reported that after cutting pin, upper disk was loosened.No injury for patient was reported.

• 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
• MDR Report Key: 7562294
• MDR Text Key: 109888545
• Report Number: 9610612-2018-00218
• 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
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF491T
• Device Catalogue Number: FF491T
• Device Lot Number: 51926102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Distributor Facility Aware Date: 05/09/2018
• Device Age: 5 YR
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2013
• 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