MAUDE Adverse Event Report: DEPUY ORTHOPEDICS INC DELTA XTEND (METAGLENE CENTRAL GUIDE PIN); PROSTHESIS, SHOULDER, HEMI-HUMERAL, METALLIC UNCEMENTED

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  No Answer Provided  

Event Description

Guide pin not removed by drill bit.

• Brand Name: DELTA XTEND (METAGLENE CENTRAL GUIDE PIN)
• Type of Device: PROSTHESIS, SHOULDER, HEMI-HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPEDICS INC
• MDR Report Key: 8396254
• MDR Text Key: 138213962
• Report Number: MW5084686
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR