MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 XTND GLENO D38MM +4MM; SHOULDER IMPLANT

Model Number 1307-64-138

Device Problem Difficult to Insert (1316)

Patient Problem Not Applicable (3189)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Its employees caused or contributed to the potential event described in this report.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 glenosphere threads would not engage into the metaglene.Waste 3 glenosphere until the metaglene was revised.Threads appeared to be damaged.Surgeon suggested that perhaps the threads in the metaglene were not spec.30 minutes of surgical delay.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: evaluation of the returned device confirms the reported event.This analysis does not highlighted any supplier defect and the need of corrective actions 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: XTND GLENO D38MM +4MM
• Type of Device: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9538901
• MDR Text Key: 184369030
• Report Number: 1818910-2020-00109
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295502456
• UDI-Public: 10603295502456
• 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
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1307-64-138
• Device Catalogue Number: 130764138
• Device Lot Number: D19031701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR