MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA RADIOLUCENT HALO RING ASSY; RETRACTOR SYSTEM COMPONENTS

Catalog Number 443A1000

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is 1 of 3 reports for part #443a1000, linked to mfg report numbers: 3004608878-2022-00159; 3004608878-2022-00160.A facility reported that the 3 parts of the radiolucent halo ring assembly shrunk in the first sterilization cycle which made it impossible to use because they were not getting connected to each other.The incident occurred during the first surgery itself as the whole system had never been used.The medical staff had to change the entire radiolucent mayfield system to standard mayfield system and use the standard budde halo for the surgery.There was no patient injury since it was not used on the patient; however, this led to increased surgery time of 90 minutes.

Manufacturer Narrative

The radiolucent budde halo retractor system (a1096) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - inspection of the returned budde halo system confirms the reported complaint.The two halves of the halo ring were not able to be connected completely at the starburst teeth.The frame of the budde halo can become altered and subsequently not fit correctly following routine use and sterilization cycles.Root cause - this device is subject to wear from routine use and as a result requires routine service and preventive maintenance.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: RADIOLUCENT HALO RING ASSY
• Type of Device: RETRACTOR SYSTEM COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15176131
• MDR Text Key: 304977421
• Report Number: 3004608878-2022-00158
• Device Sequence Number: 1
• Product Code: GZT
• Combination Product (y/n): N
• PMA/PMN Number: K830332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 443A1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• 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