MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS STRAIGHT INSERTER SHAFT; INSERTION DEVICES

Catalog Number	201007110
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent an unknown surgery with the inserter shaft and the universal stem insert handle.During surgery, the inserter shaft and the handle could not be mated.The surgeon fitted the instruments forcefully, and the surgery was proceeded.The surgery was completed successfully without any surgical delay.No further information is available.
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).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed, as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown.Therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, that 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, the patient underwent an unknown surgery with the inserter shaft and the universal stem insert handle.During surgery, the inserter shaft and the handle could not be mated.The surgeon fitted the instruments forcefully, and the surgery was proceeded.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis found that the sample was returned assembled with the mating device.Excessive force was applied to separate the devices, and revealed the actis straight inserter shaft assembly segment of the device presents a deformed condition consistent with heavy and constant use.The damage characteristics are consistent with rotating bending off-center irregular impactions which may accelerate bending propagation over multiple impaction cycles.Consistently impacting the device in the center of the cap may diminish the risk of damage, however, lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A functional test was performed with a mat component and it was found that, due to the deformation the device, it presented resistance when assembled and disassembled.Confirming the reported allegation.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the actis straight inserter shaft would have contribute to the alleged device issue.Based on the investigation findings, the potential cause is traced to end of life, 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ACTIS STRAIGHT INSERTER SHAFT
• Common Device Name: INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19078193
• Report Number: 1818910-2024-07959
• Device Sequence Number: 20502416
• Product Code: LXH
• UDI-Device Identifier: 10603295393993
• UDI-Public: (01)10603295393993(10)SO2037515
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 04/10/2024

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: 201007110
• Device Lot Number: SO2037515
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 05/01/2024; 06/06/2024; 09/23/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/22/2024; 05/03/2024; 06/07/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown