MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTND GLENO D38MM +4MM; SHOULDER IMPLANT

Model Number	1307-64-138
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
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
Intraoperatively during a primary shoulder-tep right side it was not possible to connect the glenosphere to metaglene.No surgical, no adverse patient consequences.Procedure was finished successfully as another glenosphere was available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : evaluation of the returned device confirmed 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.
Additional 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.

• Brand Name: XTND GLENO D38MM +4MM
• Common Device Name: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11311242
• Report Number: 1818910-2021-02777
• Device Sequence Number: 1166908
• Product Code: PHX
• UDI-Device Identifier: 10603295502456
• UDI-Public: 10603295502456
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2021

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: 1307-64-138
• Device Catalogue Number: 130764138
• Device Lot Number: D20080087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/10/2021; 03/17/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/16/2021; 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1