MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KIT, TOTAL HIP, PRESBYTERIAN (HA10V)930; ORTHOPEDIC TRAY

Model Number	POV2THA110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported suction tip broke inside patient femur bone during total hip case.The item is retained in patient, but no further injury reported.¿disclosure made to the patient regarding decision not to do anything further to remove it since the risks outweighed benefits.".
Additional Manufacturer Narrative
The device was not returned for evaluation; however, a photo was received which showed two devices.The photo showed one yankauer without any visible damage, and another yankauer with the reported condition (broken).The picture of the broken device showed the breakage occurred on the angle section, and the cut is observed to be straight.Since no sample was received for evaluation, a laboratory test of molecular composition of the product could not be performed.The complaint has been confirmed based on the photo provided, however, the root cause is unable to be determined.The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The reported failure mode could not be duplicated during the investigation.

• Brand Name: KIT, TOTAL HIP, PRESBYTERIAN (HA10V)930
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood dr.; waukegan IL 60085
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15611169
• Report Number: 1423537-2022-00852
• Device Sequence Number: 6463350
• Product Code: OJH
• UDI-Device Identifier: 10195594777975
• UDI-Public: 10195594777975
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: POV2THA110
• Device Catalogue Number: POV2THA110
• Device Lot Number: 885985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male