MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND GLENOSPHERE STD D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number	130760142
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Intraoperatively during initial surgery right side it was not possible to fix the glenosphere to the metaglene.Another glenosphere was available and used without any issue.No surgical delay, no adverse patient consequences.
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 # (b)(4).Investigation summary : intraoperatively during initial surgery right side it was not possible to fix the glenosphere to the metaglene.Another glenosphere was available and used without any issue.No surgical delay, no adverse patient consequences.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the device found the threaded shaft stripped, the observed condition could have contributed to the mating issues with the metaglene.The condition in which the device was received and opened remains unknown.Per the delta xtend¿ reverse shoulder system surgical technique 103333-220905 (page 34), "proper alignment between the glenosphere and metaglene is absolutely essential to avoid cross threading between the components.Proper alignment leads to smooth thread engagement and easy screwing.If the glenosphere seems difficult to thread onto the metaglene, do not force engagement but re-align the components.If necessary remove the inferior retractor or improve the capsular release." a dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test was unable to be performed as its mating device was not returned.The overall complaint was confirmed as the observed condition of the dxtend glenosphere std d42mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product description: dxtend glenosphere std d42mm.Product code: 130760142.Lot number: 5500057.Please provide: 1) quantity manufactured: 30.2) date of manufacture: 03/03/23.3) any anomalies or deviations identified in dhr: n/a.4) expiry date: 01/31/2028.5) ifu reference: w90930 rev.D.The dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non conformance.Corrected h3.

• Brand Name: DXTEND GLENOSPHERE STD D42MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17288931
• Report Number: 1818910-2023-13814
• Device Sequence Number: 17729279
• Product Code: HSD
• UDI-Device Identifier: 10603295027775
• UDI-Public: 10603295027775
• 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): 07/10/2023

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: 130760142
• Device Catalogue Number: 130760142
• Device Lot Number: 5500057
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 08/15/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/03/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown