MAUDE Adverse Event Report: AESCULAP AG KERRISON BLK COATED 130 UP 200X2MM REG; MICRO NEUROSURGICAL INSTR. / D

Model Number FK913B

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the instrument arrive in a decontaminated condition and available for investigation.During inspection and cleaning phase the tip is broken.According to the available information, there were no negative consequences for the patient.The instrument arrived in a clean status without the broken off tip and fragments.The components have been examined visually and microscopically with the digital microscope.A visual inspection of the instrument was performed the broken off tip is missing.Furthermore a visual inspection of the fracture surface was also performed.A light brown discoloration and a crack was found.Hardness of the instrument was checked and according to specification it is in the allowable tolerance.The device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.The root cause of the problem is most probably usage related.A capa in not necessary.

Event Description

(b)(6).During cleaning the tip broke off.

• Brand Name: KERRISON BLK COATED 130 UP 200X2MM REG
• Type of Device: MICRO NEUROSURGICAL INSTR. / D
• 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: 7271725
• MDR Text Key: 100141093
• Report Number: 9610612-2018-00044
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: LY
• PMA/PMN Number: EXEMPT
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FK913B
• Device Catalogue Number: FK913B
• Device Lot Number: 52071758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2017
• Distributor Facility Aware Date: 01/23/2018
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other