MAUDE Adverse Event Report: DEPUY IRELAND 9616671 XTND GLENO D38MM +6MM; DELTA XTEND

Model Number 1307-66-138

Device Problems Difficult to Insert (1316); Device Damaged Prior to Use (2284)

Patient Problem No Code Available (3191)

Event Date 07/22/2020

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

It was reported that the threads of the glenosphere would not engage into the metaglene.The thread damage is visible, surgeon feels there's a design issue with the threads.There was a surgical delay of 5 mins.Doe: (b)(6) 2020.Affected side: left.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: evaluation of the returned device confirms the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: XTND GLENO D38MM +6MM
• Type of Device: DELTA XTEND
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10355873
• MDR Text Key: 201401936
• Report Number: 1818910-2020-17345
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295502616
• UDI-Public: 10603295502616
• Combination Product (y/n): N
• PMA/PMN Number: K183077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020

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 Model Number: 1307-66-138
• Device Catalogue Number: 130766138
• Device Lot Number: D19072228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 08/31/2020
• Supplement Dates FDA Received: 08/29/2020; 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER METAGLENE
• Patient Age: 80 YR