MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE ECC D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number	130760038
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2021
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 primary shoulder-tep unknown side it was not possible to connect the glenosphere to the metaglene.Another glenosphere was available and procedure was completed successfully.No patient harm, no adverse consequences.Surgical delay 10 min.
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: evaluation of the returned device confirms the reported event.The analysis does not highlighted any supplier defect and the need of corrective actions is not indicated.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: 1) quantity manufactured: 30.2) date of manufacture: 11-march-2020.3) any anomalies or deviations identified in dhr: the dhr review of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there were no deviations or non-conformances.4) expiry date: 31-october-2025.5) ifu reference: w90930, corrected: h3.

• Brand Name: DXTEND GLENOSPHERE ECC D38MM
• Common Device Name: DELTA XTEND IMPLANTS : 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: 11553209
• Report Number: 1818910-2021-05796
• Device Sequence Number: 14475018
• Product Code: PHX
• UDI-Device Identifier: 10603295027744
• UDI-Public: 10603295027744
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2021

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: 130760038
• Device Catalogue Number: 130760038
• Device Lot Number: 5371984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 05/13/2021; 07/01/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/21/2021; 07/02/2021
• 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: DXTEND GLENOSPHERE ECC D38MM; DXTEND METAGLENE; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND GLENOSPHERE ECC D38MM; DXTEND METAGLENE; DXTEND SCREW NO LOCK D4.5X18MM