MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 8; HIP FEMORAL STEM

Catalog Number	101012080
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively on (b)(6) 2024, during impaction of an actis stem the impaction instrument´s thread fractured.The instrument fractured into two parts.The fragment remained inside the stem´s hole.Another stem and another impactor were used without issues.There was 10 minutes surgical delay.No adverse patient consequences.
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 medwatch, a follow-up medwatch 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.H11 additional narrative: added: d9.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: intraoperatively during impaction of an actis stem the impaction instrument´s thread fractured.The instrument fractured into two parts.The fragment remained inside the stem´s hole.Another stem and another impactor were used without issues.No adverse patient consequences; surgical delay 10 minutes.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis found that the actis collared high size 8 was returned disengage from its mating device.There was no damage or defects.The device does not present any signs of issue or malfunction, only a fragment of the tip of the actis retaining stem inserter was remained inside the insertion hole, it cannot be retrieved and exhibits sings of implantation attempts at the distal section.A manufacturing record evaluation was performed for the finished device [101012080/ m5581n] and no non-conformances / manufacturing irregularities were identified.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the actis collared high size 8 would have not contributed to the complained issue.Based on the investigation findings, 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 j&j medtech orthopaedics 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 = > 1) quantity manufactured: (b)(4).2) date of manufacture: 04/18/2024.3) any anomalies or deviations identified in dhr: none.4) expiry date: 03/31/2034.5) ifu reference: ifu 090200877 rev.E.Device history review: a manufacturing record evaluation was performed for the finished device [101012080/ m5581n] and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: ACTIS COLLARED HIGH SIZE 8
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20725166
• Report Number: 1818910-2024-24080
• Device Sequence Number: 3850400
• Product Code: MEH
• UDI-Device Identifier: 10603295380603
• UDI-Public: (01)10603295380603(17)340331(10)M5581N
• 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

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: 101012080
• Device Lot Number: M5581N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 02/04/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/06/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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