MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MOD CENT EPI 1 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number	130720101
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2021
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 two implants were opened and were found to have a defective problem with putting them together.The epi stem would not fit into the opening on the unite stem.Minimal surgical time was wasted and the problem implants were never introduced to the patient.There was no implant/explant as the problem was detected early and all parts were retrieved for return.
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 130720101, work order (b)(4) was manufactured on 02-jul-2021.All raw materials met specification.9 parts were manufactured to specification.3 parts from this lot were scrapped.Scrap code a1094: this concerns epi ctq 2 ¿ taper circlarity.There is no correlation between this scrap reason and the failure mode of the complaint.Scrap code a866: this concerns ha coating defects.There is no correlation between this scrap reason and the failure mode of the complaint.Scrap code a211: this concerns scratches.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.Cmm reports for ctq23_spigot_diameter for all parts in batch were reviewed and found to be within specification but all close to the limits of top tolerance with results from 7.992-7.993mm versus a specification of 7.959 ¿ 7.995mm.Device history review: a review was completed of the dxtend mod cent epi 1 ha (product code: 130720101 lot number: 9827963) device history record (dhr) and no nonconformances were found.

• Brand Name: DXTEND MOD CENT EPI 1 HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12358430
• Report Number: 1818910-2021-18458
• Device Sequence Number: 17077627
• Product Code: HSD
• UDI-Device Identifier: 10603295027287
• UDI-Public: 10603295027287
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/02/2021

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: 130720101
• Device Catalogue Number: 130720101
• Device Lot Number: 9827963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 05/11/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 08/25/2021; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLOBAL UNITE STD STEM SZ 8
• Patient Sex: Female