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

Catalog Number 950501235

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported sigmal distal fem connector is locked inside distal fem resection guide.No surgical delay.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
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> functional examination of the returned device could not replicate the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: SIGMA HP DIS FEM RESECT GUIDE
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7553569
• MDR Text Key: 109538342
• Report Number: 1818910-2018-60857
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295225409
• UDI-Public: 10603295225409
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 950501235
• Device Lot Number: SO2003824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR