MAUDE Adverse Event Report: KYOCERA MEDICAL TECHNOLOGIES, INC. KYOCERA MEDICAL TECHNOLOGIES, INC; TESERA SCREW, SELF DRILLING 4.0 X 12 MM

Catalog Number	1050-140-012
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, an expired implant was inadvertently implanted into a patient on (b)(6) 2023, in australia.There has been no reported patient injury/infection to date.No revision surgery was reported.The expiration date is located on multiple layers of the packaging.This event is confirmed as a user related error with no malfunction of the device.A review of manufacturing records confirms the product was manufactured to specification and there is no indication of product quality issues with respect to design, manufacturing, or labeling.The product remains implanted in the patient and will not be revised/returned.This issue was added to an internal capa to address expired or expiring inventory consigned with independent sales representatives.Since this product was implanted, kmti located 10 packaged implants from a similar lot that has the same packaging configuration and that had expired on 01/20/2022.The packaging on these 10 implants was tested at pro-tech design and mfg (santa fe springs, ca) to assess whether the packages had retained sufficient package seal strength (n=10) and packaging seal integrity (bubble emission, n=10) test results were acceptable for both tests (test name job 31130-01 and tr-23-045-01).The testing showed expired implants most likely retained sufficient seal strength and seal integrity after being expired for more than 20 months.Should additional information be provided by the healthcare provider, a supplemental mdr will be submitted.
Event or Problem Description
An expired implant was used in surgery on (b)(6) 2023.The implant expired on september 6,2023.

• Brand Name: KYOCERA MEDICAL TECHNOLOGIES, INC
• Common Device Name: TESERA SCREW, SELF DRILLING 4.0 X 12 MM
• Manufacturer (Section D): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california st; suite 210; redlands 92374
• Manufacturer (Section G): KYOCERA MEDICAL TECHNOLOGIES, INC.; 1200 california street; suite 210; redlands 92374
• Manufacturer Contact: anthony debenedictis ; 1200 california st; suite 210; redlands 92374 ; 9095572360
• MDR Report Key: 19056126
• Report Number: 3015398319-2024-00001
• Device Sequence Number: 6677063
• Product Code: OVE
• UDI-Device Identifier: 00841523117949
• UDI-Public: 00841523117949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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 Expiration Date: 09/06/2023
• Device Catalogue Number: 1050-140-012
• Device Lot Number: 11386-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male