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

Model Number	439A1092
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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¿
• Common Device Name: 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
• Report Number: 3004608878-2023-00001
• Device Sequence Number: 15321045
• Product Code: HBL
• UDI-Device Identifier: 10381780253341
• UDI-Public: 10381780253341
• Combination Product (Y/N): N
• PMA/510(K) Number: K130389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown