MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SPECIALIST*2 UNIVERSAL HANDLE; KNEE INSTRUMENT : HANDLES

Catalog Number	966520
Medical Device Problem Codes	Device-Device Incompatibility (2919); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
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
It was reported that on (b)(6) 2024, the patient underwent the surgery via tka for the right knee joint with the handle in question.To place the femoral component, the handle in question was connected to the femoral impactor and struck.However, the tip of the handle in question was damaged during the process.Since it could not be connected to the femoral impactor, another device was substituted.It was thought that deterioration over time was the cause.The surgery was completed successfully without any surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "it was reported that on (b)(6) 2024, the patient underwent the surgery via tka for the right knee joint with the handle in question.To place the femoral component, the handle in question was connected to the femoral impactor and struck.However, the tip of the handle in question was damaged during the process.Since it could not be connected to the femoral impactor, another device was substituted.It was thought that deterioration over time was the cause." the product was returned to depuy synthes, evaluation of the physical device revealed that the tip of specialist*2 universal handle fractured from the distal square-to-circular section tip.The device interaction allegation can be attribute to broken condition of the tip.The square-to-circular section tip are not meant to be disassemble.Additionally the overall appearance of the device is worn most likely for the use and service through the years.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The 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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the specialist*2 universal handle would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed 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 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).Investigation summary : according to the information received, "it was reported that on (b)(6) 2024, the patient underwent the surgery via tka for the right knee joint with the handle in question.To place the femoral component, the handle in question was connected to the femoral impactor and struck.However, the tip of the handle in question was damaged during the process.Since it could not be connected to the femoral impactor, another device was substituted.It was thought that deterioration over time was the cause." the product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photo investigation revealed that the tip of specialist*2 universal handle fractured from the distal square-to-circular section tip.The device interaction allegation can be attribute to broken condition of the tip.The square-to-circular section tip are not meant to be disassemble.Additionally the overall appearance of the device is worn most likely for the use and service through the years.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The 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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the specialist*2 universal handle would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed 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 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 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).Investigation summary - according to the information received, "it was reported that on (b)(6) 2024, the patient underwent the surgery via tka for the right knee joint with the handle in question.To place the femoral component, the handle in question was connected to the femoral impactor and struck.However, the tip of the handle in question was damaged during the process.Since it could not be connected to the femoral impactor, another device was substituted.It was thought that deterioration over time was the cause." the product was returned to depuy synthes, evaluation of the physical device revealed that the tip of specialist*2 universal handle fractured from the distal square-to-circular section tip.The device interaction allegation can be attribute to broken condition of the tip.The square-to-circular section tip are not meant to be disassemble.Additionally the overall appearance of the device is worn most likely for the use and service through the years.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The 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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the specialist*2 universal handle would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed 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 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.

• Common Device Name: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18539987
• Report Number: 1818910-2024-01354
• Device Sequence Number: 6412094
• Product Code: LXH
• UDI-Device Identifier: 10603295248644
• UDI-Public: 10603295248644
• 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): 01/18/2024

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: 966520
• Device Lot Number: J1005
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 02/08/2024; 02/19/2024; 04/05/2024; 04/10/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/08/2024; 02/21/2024; 04/09/2024; 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2005
• 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