MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 XTND GLENO D42MM +2MM; SHOULDER GLENOSPHERE

Model Number	1307-62-142
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the glenosphere would not mate with the metaglene.This was tried multiple times and the internal screw in piece would not engage with the metaglene.No fault of the surgeon.There was a surgical delay of 30 mins.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.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.

• Brand Name: XTND GLENO D42MM +2MM
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10434223
• Report Number: 1818910-2020-18490
• Device Sequence Number: 2801282
• Product Code: HSD
• UDI-Device Identifier: 10603295502500
• UDI-Public: 10603295502500
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K183077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1307-62-142
• Device Catalogue Number: 130762142
• Device Lot Number: D19051764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SHOULDER METAGLENE