MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP DIS FEM RESECT GUIDE; RESECTION BLOCKS/DEVICES

Catalog Number	950501235
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
It was reported that when assembling the distal femoral cutting guide the dial would not slide freely on the arms.It could not be removed.A new tray was opened to complete the case.
Additional Manufacturer Narrative
Investigation summary: the device associated with this report was not returned for examination.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, will be filed as appropriate.

• Brand Name: SIGMA HP DIS FEM RESECT GUIDE
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7193375
• Report Number: 1818910-2018-51287
• Device Sequence Number: 1394455
• Product Code: HWT
• UDI-Device Identifier: 10603295225409
• UDI-Public: 10603295225409
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2017

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 Catalogue Number: 950501235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1