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

Catalog Number 950501118

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2019

Event Type  malfunction  

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 Description

Hcp reported the instrument to be broken in one or more parts.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the device was reviewed and confirmed the failure mode the device has broken.Root cause attributed to product design.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS HP DIST BLOCK
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8835873
• MDR Text Key: 152647372
• Report Number: 1818910-2019-99456
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295224785
• UDI-Public: 10603295224785
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950501118
• Device Lot Number: J0609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1