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

Catalog Number	101011070
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was sterile plastic packaging around implant contained a sizable hole and crack in causing sterility to be questioned.There was no damage to the box that the implant came in.The nurse did not mishandle the packaging.It was noticed before transfer to sterile field.Due to question of sterility of packaging, implant was not used and a different implant was opened.Doe: (b)(6) 2024.Affected side: unknown hip side.
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.
Event or Problem Description
Additional information was received: the implant in question is an actis sz 7 standard stem.Reference number: 1010-11-070.Lot number: 3876457.The patient was not harmed because the implant was not used due to questionable sterility of the implant itself.A different stem of the same size was used without any issue in its packaging.There was a delay in the surgery of about 10 minutes since i had to obtain a new actis stem sz 7 std for use in the case.Thankfully we had another stem on hand and were able to complete the case without a more significant delay.If this were not the case, the delay could have been upwards of an hour.
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.H10 additional narrative: added: a1, a2, b5 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: it was reported that on (b)(6) 2024, there was sterile plastic packaging around implant contained a sizable hole and crack in causing sterility to be questioned.There was no damage to the box that the implant came in.The nurse did not mishandle the packaging.It was noticed before transfer to sterile field.Due to question of sterility of packaging, implant was not used and a different implant was opened.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the outer cardboard box of the actis collared std size 7 was severely damaged at the right side, the shrink-wrap plastic was torn.Additionally the tyvek seal was completely removed and was not returned, the blister packaging was damaged too, matches with the damaged found at the right side of the outer cardboard.The inner pouch had not been opened, and the integrity of the pouch seal was intact.It can therefore be concluded that there is no impact on sterility of the device.The potential cause of the observed complaint condition cannot be traced to a manufacturing issue.Once the product leaves depuy synthes control, it is unknown what environment conditions or human intervention or manipulation the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of depuy synthes control.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the actis collared std size 7 would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ACTIS COLLARED STD 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 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19837280
• Report Number: 1818910-2024-15899
• Device Sequence Number: 17804434
• Product Code: MEH
• UDI-Device Identifier: 10603295380474
• UDI-Public: (01)10603295380474(17)320630(10)3876457
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/26/2024

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: 101011070
• Device Lot Number: 3876457
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 08/05/2024; 09/10/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/01/2024; 08/08/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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 Age: 75 YR
• Patient Sex: Unknown