MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER GLENOSPHERE DELTA XTEND

Catalog Number UNK SHOULDER GLENOSPHERE DELTA

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/26/2020

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

I covered a reverse shoulder today in which they used our delta xtend kit.They had issues with a locking screw separating as they placed it ¿ and as a result difficulties extracting it to replace with another ¿ the issue was however resolved.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• Brand Name: UNK SHOULDER GLENOSPHERE DELTA XTEND
• Type of Device: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10672967
• MDR Text Key: 212530315
• Report Number: 1818910-2020-22209
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOSPHERE DELTA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHOULDER METAGLENE