MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE REV STEM SZ 8; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	1100-08-600
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2020
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 the proximal body would not mate with the stem, we tried the trial proximal body with the stem and it would not mate, we tried the proximal body with the trial stem and it would mate.So we opened a second stem and the problem was solved.There was no harm done to to the patient a surgical delay was noted.
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 = > functional testing of the returned device confirmed the reported event.The root cause was attributed to a tolerance issue.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 = > a search of the depuy nonconformance (nc) quality system found one related nc associated with this product.On the (b)(6)2017, a complaint investigation (b)(4) found that a global unite stem part that had been returned was out of specification as per test method tm-101453 rev.3 ¿go/nogo gauge inspection of global unite stems at machining¿.The part was from lot 8441321.Capa-007291 was raised to address the non conforming condition identified during the inspection of the global unite stems as per (b)(4).A product issue assessment (pia 886857) was also conducted as part of the previous non conforming condition identified during the inspection of the global unite stems as per com-280266.Corrected: h3, h8.

• Brand Name: GLOBAL UNITE REV STEM SZ 8
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11155377
• Report Number: 1818910-2021-00904
• Device Sequence Number: 3878656
• Product Code: HSD
• UDI-Device Identifier: 10603295004059
• UDI-Public: 10603295004059
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/30/2020

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: 1100-08-600
• Device Catalogue Number: 110008600
• Device Lot Number: 9242273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 04/05/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 01/14/2021; 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1