MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 LCS HP FEM NOTCH IMPACTOR; KNEE INSTRUMENT : IMPACTORS

Model Number	9505-01-219
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
As sterile processed loan trays for lcs tkr were being opened in theatre, the scrub nurse noticed a white substance on the tibial and femoral impactor.The substance appeared to be cement from previous use.On inspection of other trays by rep (myself), it was noticed that some instrumentation was not disassembled from previous cases.The surgeon was made aware of the contamination and the surgery was cancelled.The surgeon spoke with the patient and rebooked the case for two weeks time.
Event or Problem Description
1.Kindly clarify why some instrumentation was not disassembled, was there any product issue of these products? ¿ where appropriate instruments that require it are disassembled during the inspection process.In these specific cases the instruments are then reassembled and placed back into the tray as this is how they fit into the trays.They are not sent to customers disassembled.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: LCS HP FEM NOTCH IMPACTOR
• Common Device Name: KNEE INSTRUMENT : IMPACTORS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10919343
• Report Number: 1818910-2020-25619
• Device Sequence Number: 16812152
• Product Code: HWA
• UDI-Device Identifier: 10603295225263
• UDI-Public: 10603295225263
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020

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: 9505-01-219
• Device Catalogue Number: 950501219
• Device Lot Number: PO0508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 12/01/2020; 02/03/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 12/11/2020; 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1