MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 7; HIP FEMORAL STEM

Catalog Number	101012070
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer is complaining that the product's sterile packaging of the stem is also shrink-wrapped in the plastic packaging, which makes correct opening impossible.There was a femoral socket with the product.No adverse patient consequences, no surgical delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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).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 = > customer is complaining the product as the sterile packaging of the stem is also shrink-wrapped in the plastic packaging, which makes correct opening impossible.There was a femoral socket with the product.No adverse patient consequences, no surgical delay reported.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample was performed on actis collared high size 7 was found that a section of the bag that contains the device was trapped between the seal area of blister and tyvek.Also was observed a narrow sealing margin and it appears that sterility was not compromised.The overall complaint was confirmed as the observed condition of the actis collared high size 7 would contribute to the complained device issue.Based on the information currently available, a manufacturing product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > product description: actis collared high size 7 product code: 101012070 lot number: m05r12 1) quantity manufactured: 10 2) date of manufacture: (b)(6) 2022 3) any anomalies or deviations identified in dhr: none 4) expiry date: 2032-10-31 5) ifu reference: ifu-0902-00-877 rev.B device history review = > a manufacturing record evaluation was performed for the finished device [(b)(4)], and no non-conformances / manufacturing irregularities were identified.H3.

• Brand Name: ACTIS COLLARED HIGH SIZE 7
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17956918
• Report Number: 1818910-2023-21262
• Device Sequence Number: 5295464
• Product Code: MEH
• UDI-Device Identifier: 10603295380597
• UDI-Public: 10603295380597
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

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 Catalogue Number: 101012070
• Device Lot Number: M05R12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 01/19/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/28/2023; 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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
• Patient Sex: Unknown