MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 XTND GLENO ECC D38MM +2MM

Model Number 1307-62-038

Device Problems Device Damaged Prior to Use (2284); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

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

It was reported that the thread pitch on glenosphere was off.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: evaluation of the returned device confirms the reported event.This analysis does not highlight any supplier defect and the need of corrective action is not indicated.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.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information was received stating that there wasn't any loosening.When the surgeon was inserting the glenosphere the screw just spun.It had to do with the thread pitch.We opened another one and it inserted immediately.

• Brand Name: XTND GLENO ECC D38MM +2MM
• Type of Device: XTND GLENO
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 10449561
• MDR Text Key: 204239136
• Report Number: 1818910-2020-18714
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295502432
• UDI-Public: 10603295502432
• 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: 08/13/2020

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: 1307-62-038
• Device Catalogue Number: 130762038
• Device Lot Number: D19030845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 09/22/2020
• Supplement Dates FDA Received: 09/03/2020; 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1