MAUDE Adverse Event Report: RENOVIS SURGICAL TECHNOLOGIES RENOVIS; TIBIAL BASEPLATE CEMENTED KEELED

Model Number	A200
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/26/2016
Additional Manufacturer Narrative
On (b)(6) 2016, dr.(b)(6) informed dr.(b)(4), president and ceo of renovis surgical technologies, via electronic mail that a r tibial baseplate cemented keeled sz 8 (lot #2280-6) was labeled incorrectly as a r tibial baseplate cemented keeled sz 6 (lot #2280-4) and implanted into a patient.An investigation was initiated and manufacturing records were reviewed in order to determine how the error occurred.A re-inspection of part # 1202-222-800, lot #2280-6 was performed by qc inspector ((b)(4)) on 09/27/2016.(b)(4) units from lot 2280-6 were found to be packaged and labeled to the correct specifications.One unit labeled a r tibial baseplate cemented keeled size 8, p/n 1202-222-800, lot #2280-6 was in fact, a r tibial baseplate cemented keeled size 6, p/n 1202-222-600 from lot #2280-4.The size and lot markings on the physical device did not match the information on the labeling.It was determined that the error occurred during the packaging process.Packaging subcontractor ((b)(4)) was contacted regarding the non-conformance and initiated an internal investigation.Through their investigation it was determined that the mix-up occurred during the toc extraction process.One unit of each lot being packaged is removed and placed into separate beakers in the toc extraction area.The toc extraction is performed and the parts are then individually placed into a primary sterile barrier (pouch) and returned to the product group from which they were removed.It was during this step that the parts were returned to the incorrect group.(b)(4) is implementing a second part # / lot# verification step after toc extraction in order to prevent the same type of error from occurring in the future.
Event or Problem Description
On (b)(6) 2016, dr.(b)(6) informed dr.(b)(4), president and ceo of renovis surgical technologies, via electronic mail that a r tibial baseplate cemented keeled sz 8 (lot #2280-6) was labeled incorrectly as a r tibial baseplate cemented keeled sz 6 (lot #2280-4) and implanted into a patient.

• Brand Name: RENOVIS
• Common Device Name: TIBIAL BASEPLATE CEMENTED KEELED
• Manufacturer (Section D): RENOVIS SURGICAL TECHNOLOGIES; 1901 w. lugonia ave.; suite 340; redlands CA 92374
• MDR Report Key: 6058024
• Report Number: 3007932279-2016-00003
• Device Sequence Number: 13459686
• Product Code: JWH
• UDI-Device Identifier: 00841523102136
• UDI-Public: 00841523102136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/26/2016

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: No Information
• Device Expiration Date: 12/31/2019
• Device Model Number: A200
• Device Catalogue Number: 1202-222-600
• Device Lot Number: 2280-4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2016
• Initial Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR