MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 XTNDGLENO ECCD42MM+0MM SHRTPST; SHOULDER GLENOSPHERE

Model Number	1307-61-042
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/09/2020
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 neither of the glenospheres would thread into the metaglene.The threads appeared to get damaged somehow.The surgeon felt like something may have been wrong with the metaglene.But the third one we tried finally threaded in.A surgical delay of 10 minutes.Doe: (b)(6), 2020 left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Corrected: d3, h8.

• Brand Name: XTNDGLENO ECCD42MM+0MM SHRTPST
• 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: 10720767
• Report Number: 1818910-2020-23112
• Device Sequence Number: 14324069
• Product Code: PHX
• UDI-Device Identifier: 10603295502609
• UDI-Public: 10603295502609
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 1307-61-042
• Device Catalogue Number: 130761042
• Device Lot Number: D20042809
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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; XTND GLENO ECC D42MM +2MM; UNKNOWN SHOULDER METAGLENE; XTND GLENO ECC D42MM +2MM
• Patient Age: 71 YR
• Patient Weight: 88