MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 LCS HP DIST BLOCK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	9505-01-118
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
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
(b)(6) hospital (b)(6) 2020; a cssd team member advised that the distal cutting block was apparently a bit sticky during the case.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device was reviewed by depuy engineering melbourne in a-4407857 which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: LCS HP DIST BLOCK
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10251001
• Report Number: 1818910-2020-15381
• Device Sequence Number: 10880239
• Product Code: NJL
• UDI-Device Identifier: 10603295224785
• UDI-Public: 10603295224785
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/23/2020

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: 9505-01-118
• Device Catalogue Number: 950501118
• Device Lot Number: J0808
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/24/2020; 10/05/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/27/2020; 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1