MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 GLOBAL UNITE STD STEM SZ 8; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	1100-08-100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2021
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
During the procedure, the surgeon noticed that mating the epiphysis to the stem seemed more difficult than usual and tried two different combinations.He successfully impacted one epiphysis to a stem and engaged the attaching screw successfully implanting both pieces and completing the surgery.No adverse events occurred beside a 3-5 minute delay when retrieving the other implants and the surgeon manually solving the issue.Doe: (b)(6) 2021.
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: examination of the returned device confirmed the reported allegation.The failure mode is consistent with an existing field action, fa 1896433.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: oms/dhr review: product code 110008100, work order 9824347 was manufactured on 29-jul-2021.All raw materials met specification.9 parts were manufactured to specification.There was no scrap associated with this lot no nonconformances were documented prior to nr-0164811 and capa-011025.The global unite stem within this complaint is part of the bounding of nr-0164811 / capa-011025 / fa-2044436.There was no material reprocessing reports (mrr) associated with this lot.Product code 110008100, work order 9824347 was manufactured on 29-jul-2021.09 parts were manufactured to specification there were no non-conformances associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.Device history review: a review was completed of the global unite std stem sz 8 (product code: 110008100 lot number: 9824347) device history record (dhr) and no nonconformances were documented prior to nr-0168411 and capa-011025.Corrected: h3.

• Brand Name: GLOBAL UNITE STD STEM SZ 8
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12850055
• Report Number: 1818910-2021-25810
• Device Sequence Number: 5094738
• Product Code: PHX
• UDI-Device Identifier: 10603295004042
• UDI-Public: 10603295004042
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2021

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: 1100-08-100
• Device Catalogue Number: 110008100
• Device Lot Number: 9824347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/26/2021; 05/11/2022
• Initial Report FDA Received Date: 11/21/2021
• Supplement Report FDA Received Date: 12/16/2021; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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 METAGLENE; DXTEND MOD CENT EPI 1 HA; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D38 +9MM; GLOBAL UNITE STD STEM SZ 8; GLOBAL UNITE STD STEM SZ 8; XTND GLENO D38MM +2MM
• Patient Age: 75 YR
• Patient Sex: Female