MAUDE Adverse Event Report: GLOBAL UNITE STD STEM SZ 10; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	1100-10-100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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
It was reported that when attempting to connect the size 1 epi to the global unite size 10 stem, the two implants would not connect due to a mismatch of the stem and hole used to connect the 2 implants.The implants were then removed from the field and two new implants were presented to the field.There was no delay in surgery and the implants on this report were never implanted in the patient.Doe: (b)(6) 2021, unknown affected side.
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.Added: d9.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 : examination of the returned device could not confirm the reported event.No evidence was found indicating product error was a contributing factor.Complaint (b)(4) was escalated to (b)(4) as although the parts were deemed acceptable, the alignment and skill required to mate the parts together requires further investigation.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : a review was completed of the device history record (dhr) and operations management system (oms) for the following: product code 110010100, work order (b)(4) was manufactured on 15-apr-2021.All raw materials met specification.(b)(4) parts were manufactured to specification.2 parts from this lot were scrapped: scrap code a495: this concerns ¿stem height.There is no correlation between this scrap reason and the failure mode of the complaint.There were no non-conformances associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.

• Brand Name: GLOBAL UNITE STD STEM SZ 10
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• MDR Report Key: 12108375
• Report Number: 1818910-2021-14255
• Device Sequence Number: 11812921
• Product Code: PHX
• UDI-Device Identifier: 10603295004080
• UDI-Public: 10603295004080
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2021

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: 1100-10-100
• Device Catalogue Number: 110010100
• Device Lot Number: 9760869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/23/2021; 10/27/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 07/06/2021; 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND MOD CENT EPI 1 HA; GLOBAL UNITE STD STEM SZ 10; DXTEND MOD CENT EPI 1 HA; GLOBAL UNITE STD STEM SZ 10