MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY VERSION ROD; SHOULDER INSTRUMENT/TRIAL

Catalog Number UNK-EXTREM

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.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 rotation indicated by the version rod did not match the humeral head anatomy and the placement of the cutting guide with the kit in question was indicating an incorrect cut.When the alternative kit was opened and used on the same patient in the same way, the cut was positioned correctly with regards to the patients anatomy.There is no obvious defect with the kit however the hospital have requested that this kit is swapped out.

• Brand Name: UNKNOWN DEPUY VERSION ROD
• Type of Device: SHOULDER INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6943536
• MDR Text Key: 89704604
• Report Number: 1818910-2017-26388
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-EXTREM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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