MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND MOD EPI 1 ECC LEFT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number	130720102
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
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.Cause traced to the mating device.There was no quality issue identified with the delta xtend epiphysis.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 130720102, work order (b)(4) was manufactured on 06-aug-2021.All raw materials met specification.11 parts were manufactured to specification.One (1) part from this lot was scrapped: - scrap code a1112: epi ctq 21 - notch symmetry at issue material process step.This concerns epi ctq 21 ¿ notch symmetry.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.Device history review : a review was completed of the dxtend mod epi 1 ecc left ha (product code: 130720102 lot number: 9858122) device history record (dhr) and no nonconformances were found.

• Brand Name: DXTEND MOD EPI 1 ECC LEFT HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• 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: 12850054
• Report Number: 1818910-2021-25809
• Device Sequence Number: 5094737
• Product Code: HSD
• UDI-Device Identifier: 10603295027294
• UDI-Public: 10603295027294
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K192448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,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 Expiration Date: 07/31/2026
• Device Model Number: 130720102
• Device Catalogue Number: 130720102
• Device Lot Number: 9858122
• 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: 08/06/2021
• 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