MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX PIN SET UNIVERS; PROSTHESIS, SHOULDER HEMI, HUMERAL METALLIC UNCEMENTED

Lot Number 10232675

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/27/2018

Event Type  malfunction  

Event Description

Guidewire was inserted into scapula and in the process, it broke off within the body of the scapula.Medial portion of the guide pin was encased in the cortical bone.Numerous attempts were made to retrieve the retained portion of the guidewire but ultimately the decision was made to leave it in the bone.

• Brand Name: ARTHREX PIN SET UNIVERS
• Type of Device: PROSTHESIS, SHOULDER HEMI, HUMERAL METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; naples FL
• MDR Report Key: 8274064
• MDR Text Key: 134196863
• Report Number: MW5083334
• Device Sequence Number: 0
• Product Code: HSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 10232675
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR