MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ROD SUPPORT CLAMP ASSEMBLY; RETRACTOR SYSTEM COMPONENTS

Catalog Number 443A1060

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

This is 2 of 3 reports for part #443a1060 of the radiolucent system, linked to mfg report numbers: 3004608878-2022-00158, 3004608878-2022-00160.A facility reported that the ¿o-rings¿ in the radiolucent rod support clamp assembly (443a1060) have come out of its original place which makes it impossible to use.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

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

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.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 o-rings had come out of place on these rod support clamp assemblies.The o-rings were either out of place, missing, or broken.As a result of the missing o-rings, the knobs were unable to stay in place within the clamp assemblies.Root cause - probable root cause is improper disassembly or mishandling of the parts.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: ROD SUPPORT CLAMP ASSEMBLY
• 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: 15176147
• MDR Text Key: 304980034
• Report Number: 3004608878-2022-00159
• 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: 443A1060
• 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