MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 PINNACLE MB HEAD TRIAL 47_28; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	221728047
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
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
Instrument stuck inside of another instrument.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, " instrument stuck inside of another instrument." the product was not returned to depuy synthes, however photos were provided for review.The photo investigation of '221728047, pinnacle mb head trial 47_28' can not confirmed the reported condition.Because functional issue can not determined by photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the pinnacle mb head trial 47_28 would not contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to cause not established 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 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.
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 : instrument stuck inside of another instrument.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the device found the 28 +0 femoral head trials, rep still inside of the pinnacle mb head trial 47_28.The device had deep scratches on the overall surface.The 28 +0 femoral head trials, rep rotated without resistance inside the device.The insertion tool was not returned for evaluation.According with the surgical technique the returned devices are matting devices.The observed condition of the device can be attributed to failure to follow instructions, this type of damage is consistent with the device being in contact with other tools like; forceps, tweezers or other tools with an edge, as well as the appearance suggest heavy usage.Properly handling and attention to the approved use of the device diminishes the risk of failure.According to the surgical technique, place the correct articul/eze head trial onto the pinnacle dual mobility head trial insertion tool by applying a force to the trial directly in line with the tool until the articul/eze trial is seated and securely in place.Insert the assembled pinnacle dual mobility head trial insertion tool into the pinnacle dual mobility head trial by holding the mobile bearing head trial in one hand and placing the articul/eze trial in the opening of the mobile bearing head trial.Apply pressure at an angle to minimize the force necessary to assemble.More force is required when attempting to insert the head trial into the mobile bearing head trial using a direct in line technique.Remove the pinnacle dual mobility head trial insertion tool, ensuring the articul/eze trial remains captured within the mobile bearing head trial by pulling the mobile bearing trial construct and the head trial insertion tool in opposite directions.Verify that the articul/eze trial can move freely within the mobile bearing head trial.To disassemble, place the mobile bearing trial assembly onto the shaft of the dual mobility head trial insertion tool.Lever out the articul/eze head trial from the mobile bearing trial at an angle similar to what you used to assemble it.Based on the above an incorrect disassembling technique is suspected as the potential root cause for the reported condition.A functional test was unable to be performed due to returned device condition.A dimensional inspection was not performed due to returned device condition.The overall complaint was unconfirmed as the observed condition of the pinnacle mb head trial 47_28 would not have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to failure to follow instructions, and it has been determined that no corrective and/or preventative action is required.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: PINNACLE MB HEAD TRIAL 47_28
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 19197213
• Report Number: 1818910-2024-09293
• Device Sequence Number: 18261051
• Product Code: HWT
• UDI-Device Identifier: 10603295520221
• UDI-Public: 10603295520221
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 04/26/2024

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: 221728047
• Device Lot Number: AZ353089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 06/24/2024; 07/04/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/01/2024; 06/25/2024; 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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