MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ¿XR2 METAL-FREE CONVERSION ADAPTOR¿; NEURO

Model Number 439A1092

Device Problem Break (1069)

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

Event Date 12/16/2022

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

A facility reported that the xr2 metal-free conversion adaptor (439a1092) force applicator was broken during operation.No patient injury has been reported; however, there was a delay of 30 minutes in surgery due to product problem.

Manufacturer Narrative

The xr2 metal-free conversion adaptor (439a1092) 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 unit confirms the reported complaint.The force applicator was broken around the threads of the carrier sleeve.No additional deficiencies were noted with the returned unit.Root cause - probable root cause is rough handling or improper handling of the unit.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: ¿XR2 METAL-FREE CONVERSION ADAPTOR¿
• Type of Device: NEURO
• 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: 16158813
• MDR Text Key: 308854365
• Report Number: 3004608878-2023-00001
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253341
• UDI-Public: 10381780253341
• Combination Product (y/n): N
• PMA/PMN Number: K130389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 439A1092
• Device Catalogue Number: ¿439A1092¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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