MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE FX RSA EPI 1; SHOULDER HUMERAL STEM ACCESSORY

Model Number	1407-20-101
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
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 shoulder-tep implantation, it was not possible to fix the inlay into the epiphysis.Another epiphysis was available and the inlay-epiphysis-construct was implanted without issues.Surgical delay about 5 minutes.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 :the device associated with this report was returned for analysis.Visual analysis revealed that the overall condition of the device is good, the global unite fx rsa epi 1 has signs of insert being implanted and removed during the procedure.Additionally, unable to fit to the mating device condition cannot be confirmed due to no mating device was returned.Therefore the report condition cannot be confirmed.No other issues were observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? dwr 103007526 rev h dimensional inspection: drawing: dwr 103007526 rev h feature: gauge diameter, (mechanism lock diameter) specification: 32.30 mm (+/- 0.03 mm) measured dimension: 32.30 mm result: conforming measurement device: caliper mitutoyo cd-6" asx id# cd78620 device history lot : product description: global unite fx rsa epi 1 product code: 140720101 lot number: 3912809 device history review : 1) quantity manufactured: (b)(4).2) date of manufacture: 9/5/2022 3) any anomalies or deviations identified in dhr: there was zero non-conformances associated with this lot.4) expiry date: 8/31/2032 5) ifu reference: ifu-0902-00-850.

• Brand Name: GLOBAL UNITE FX RSA EPI 1
• Common Device Name: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16159516
• Report Number: 1818910-2023-01198
• Device Sequence Number: 6958972
• Product Code: PHX
• UDI-Device Identifier: 10603295444749
• UDI-Public: 10603295444749
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170748
• 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): 01/13/2023

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: 1407-20-101
• Device Catalogue Number: 140720101
• Device Lot Number: 3912809
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 01/26/2023; 02/17/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/01/2023; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• 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