MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV UNITIZED

Model Number	82-3114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that during x-rays control on (b)(6) 2022, the hakim valve seemed to be broken and was removed on (b)(6) 2022.The valve was initially implanted in 2009.
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
N/a.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation: dhr - lot cjjb93, conformed to the specifications when released to stock failure analysis - the valve was visually inspected; the stator was dislodged a crack in the valve casing was also noted.The valve was dismantled and was examined under microscope at appropriate magnification: a crack and bump mark were noted in the valve casing, the spring was bent due to the hard knock, no corrosion was noted on the stator.The cam magnets were controlled; the magnets passed.The root cause for the issue reported by the customer is due to the valve receiving a hard knock causing a crack and bump marks in the valve casing a bent spring and dislodged stator.

• Brand Name: MICRO CHPV UNITIZED
• Common Device Name: CHPV
• 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: 15228081
• Report Number: 3013886523-2022-00374
• Device Sequence Number: 12225261
• Product Code: JXG
• UDI-Device Identifier: 10886704041498
• UDI-Public: (01)10886704041498(17)130731(10)CJJB93
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2013
• Device Model Number: 82-3114
• Device Catalogue Number: 823114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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