MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 11MM; CRANIAL CLOSURE

Model Number FF490T

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/20/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).During a case of three-point bone flap fixation , using craniofix2, when the surgeon cut the pin of the clamp one by one , all the three upper-disks detached from the shaft at the same time.The three failed products were replaced with brand new ones (craniofix2).Products reported in separate medwatch reports: 2916714-2016-00282; 2916714-2016-00283; 2916714-2016-00284.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 11MM
• Type of Device: CRANIAL CLOSURE
• 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: 5589339
• MDR Text Key: 43193179
• Report Number: 2916714-2016-00282
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Model Number: FF490T
• Device Catalogue Number: FF490T
• Device Lot Number: 52177633
• Distributor Facility Aware Date: 04/08/2016
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other