MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLO ADVANTAGE HD IMPACT STD; EXTREMITY INSTRUMENTS : IMPLANT STAND

Catalog Number 212802041

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

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

It was reported that the procedure was a global anatomic shoulder, primary surgery.He tried to use the head impaction stand that allows you to match the rotation of the head and then impact the head for a monoblock insertion.The stem would not properly lock into the anatomic or fracture plate.The surgeon was very upset.He ended up leaning the stem against other instruments with a towel underneath the tip, hoping that the rotation of the head was accurate and that the head seated properly on the stem there is either a problem with the stand or i did not know how to use the instrument properly, i don¿t think that i was the problem.Doi: (b)(6) 2017.

Manufacturer Narrative

(b)(4).Investigation summary the device associated with this report was not returned for evaluation.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Depuy considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

• Brand Name: GLO ADVANTAGE HD IMPACT STD
• Type of Device: EXTREMITY INSTRUMENTS : IMPLANT STAND
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7137461
• MDR Text Key: 95842309
• Report Number: 1818910-2017-52270
• Device Sequence Number: 1
• Product Code: HWA
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 212802041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR