MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 REV FEM/TIB/SLEEVE CLAMP; KNEE INSTRUMENT : CLAMPS

Catalog Number	217863134
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
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
The handle of the instrument is stuck or cannot be pushed up or down.
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: d4 (lot) and h4 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 this instrument is composed of 1 part.The handle of the instrument is stuck or cannot be pushed up or down as per the images attached.The product was not returned to depuy synthes, however photos were provided for review.See attachment (image (1).Jpg).The photo investigation revealed that rev fem/tib/sleeve clamp has signs of normal wear from constant use.However, it is not possible to confirm that the handle is stuck based on photographic evidence.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.As the device was not returned, an as-received condition could not be assessed, and a functional and dimensional inspection were not completed.The overall complaint was not confirmed as the observed condition of the rev fem/tib/sleeve clamp would not contribute to the complained 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 a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (h0108) provided is not a valid finished goods lot number.H11 additional narrative: corrected: d4 (primary udi number).
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: 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 : this instrument is composed of 1 part.The handle of the instrument is stuck or cannot be pushed up or down as per the images attached.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that rev fem/tib/sleeve clamp has signs of normal wear from constant use.However, it is not possible to confirm that the handle is stuck based on photographic evidence.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.As the device was not returned, an as-received condition could not be assessed, and a functional and dimensional inspection were not completed.The overall complaint was not confirmed as the observed condition of the rev fem/tib/sleeve clamp would not contribute to the complained 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 : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (h0108) provided is not a valid finished goods lot number.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - this instrument is composed of 1 part.The handle of the instrument is stuck or cannot be pushed up or down as per the images attached.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the rev fem/tib/sleeve clamp is worn on the surface and it is also found on the internal mechanism.This condition suggest that the device has been subjected to frequent handling and operation, likely contributing to its overall worn condition.The wrench lever is found to be stucked.This condition appears to be consistent with the wear observed in the mechanism and effects of repeated use and servicing over a period exceeding 15 years.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.A functional test was unable to be performed due to the post-manufacturing damage.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the rev fem/tib/sleeve clamp would have contributed to the complained 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 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 - a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (h0108) provided is not a valid finished goods lot number.H11 additional narrative: corrected: h3.

• Brand Name: REV FEM/TIB/SLEEVE CLAMP
• Common Device Name: KNEE INSTRUMENT : CLAMPS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 19516171
• Report Number: 1818910-2024-12747
• Device Sequence Number: 17725781
• Product Code: HXD
• UDI-Device Identifier: 10603295096238
• UDI-Public: (01)10603295096238(10)H0108
• 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,Followup
• Report Date (Section B): 06/11/2024

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: 217863134
• Device Lot Number: H0108
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 07/17/2024; 09/26/2024; 10/08/2024; 11/12/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/03/2024; 07/18/2024; 09/30/2024; 10/09/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2008
• 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