MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 XTND GLENO D38MM +4MM; SHOULDER GLENOSPHERE

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	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively the glenosphere was not possible to screw onto the metaglene.The glenosphere´s recently new designed shorter screw made it difficult to handle.Another glenoshere available and surgery was completed as intended.Surgery prolongation about 5 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device was not able to confirm the complaint since the involved mating device was not returned for a functional test.Additionally, the leading screw threads were stripped and flattened.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > 1) quantity manufactured: (b)(4) 2) date of manufacture: 29-aug-2022 3) any anomalies or deviations identified in dhr: a manufacturing record evaluation was performed for the finished device product code 130764138 and lot number d22082587, and no non-conformances were identified.4) expiry date: 31-jul-2027 5) ifu reference: msaw90930 device history review = > a manufacturing record evaluation was performed for the finished device product code 130764138 and lot number d22082587, and no non-conformance were identified.Corrected: d3, g1, h3.

• Brand Name: XTND GLENO D38MM +4MM
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15983782
• Report Number: 1818910-2022-25435
• Device Sequence Number: 17629815
• Product Code: PHX
• UDI-Device Identifier: 10603295502456
• UDI-Public: 10603295502456
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192855
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2023

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: D22082587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/06/2023; 02/28/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/09/2023; 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown