MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818 SIGMA HP SYSTEM HANDLE; KNEE INSTRUMENT : HANDLES

Catalog Number 202499111

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

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 that the sigma hp system handle broke at the tip.No surgical delay.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4) investigation summary
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> examination of the returned instrument confirmed 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 will be filed as appropriate. .

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.

• Brand Name: SIGMA HP SYSTEM HANDLE
• Type of Device: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7304042
• MDR Text Key: 101253085
• Report Number: 1818910-2018-54308
• Device Sequence Number: 1
• Product Code: LHX
• UDI-Device Identifier: 10603295084174
• UDI-Public: 10603295084174
• 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,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 202499111
• Device Lot Number: A0909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2009
• 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: 80 YR