MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER METAGLENE

Catalog Number UNK SHOULDER METAGLENE

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

Product complaint # (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: UNKNOWN SHOULDER METAGLENE
• Type of Device: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10672989
• MDR Text Key: 212553745
• Report Number: 1818910-2020-22210
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER METAGLENE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK SHOULDER GLENOSPHERE DELTA XTEND