MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ULTRA-COAT KERRISON MICRO 40D UP 9 4MM

Catalog Number RB5964

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

A facility reported that during a case for a back procedure, the screw came off the ultra-coat kerrison micro (rb5964) and fell into the patient.Two different kerrison¿s of the same lot were used.It was reported that the malfunction did not result in patient/user injury or death.No surgical delay was reported.Additional information has been requested.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Additional b5: it was reported that the staff searched for the screw that fell out of the kerrison.It is unknown whether an x-ray was performed; however, staff confirmed that all broken parts were recovered.A replacement device was available, and the procedure was completed.No adverse event occurred to the patient.The ultra-coat kerrison micro (rb5964) was returned for evaluation: failure analysis: the ultra-coat kerrison was returned in used condition with the set screws in place.Damage due to wear was noted on the set screws.These kerrison may have been reassembled prior to return.Root cause analysis: the complaint reported by the customer was confirmed.The issue of worn set screws may cause them to loosen if not assembled securely before use.No manufacturing, workmanship or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: ULTRA-COAT KERRISON MICRO 40D UP 9 4MM
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12954949
• MDR Text Key: 286948344
• Report Number: 3014334038-2021-00250
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K182259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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: Health Professional
• Device Catalogue Number: RB5964
• Device Lot Number: AH1910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1