MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  malfunction  

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 Description

It was reported that the box of cement was opened.The liquid portion had a crack in the bottle.The cement was discarded and never entered the sterile field.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary the device has not been returned for examination, and no other evidence to aid investigation has been supplied.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 required.Device history lot device history reviewed: 0 non-conformance on this lot.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional report related to possible broken ampoules.Total for lot number: 2 ((b)(4), (b)(4)).Complaints received by cmw in the last 12 months for this issue ¿ by product code: 2.By product family: 4 (2x smartset ghv, 2x smartset gmv).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: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw 46582
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 7809051
• MDR Text Key: 117995722
• Report Number: 1818910-2018-67524
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 8643915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1