MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP SYSTEM HANDLE; KNEE INSTRUMENT : HANDLES

Catalog Number	202499111
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2024
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 instrument´s locking mechanism cannot be opened, it is stuck.
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.
Event or Problem Description
Additional information received states that the procedure was successfully completed and no fragments were generated.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the instrument´s locking mechanism cannot be opened, it is stuck.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed the overall sigma hp system handle with signs of normal usage.A dimensional inspection was not performed since it was not applicable to the complaint condition.The functional test performed revealed a difficulty while locking and unlocking the lever on the locking mechanism.Galling is suspected to have internally occurred between the lever pins and the lever component causing the internal metal components to begin to seize.Potential cause for this condition can be traced to improper maintenance, as device should be lubricated with a water soluble lubricant after each use, as labeled on the distal portion of device and stated on the cleaning instructions of the ifu-0902-00-721 document.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.The overall complaint was confirmed as the observed condition of the sigma hp system handle would have contributed to the complained device 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: quantity manufactured: (b)(4).Date of manufacture: 8/21/2019.Any anomalies or deviations identified in dhr: no.Expiry date: n/a.Ifu reference: ifu nonsterile inst rev j.Device history review: quantity manufactured: (b)(4).Date of manufacture: 8/21/2019.Any anomalies or deviations identified in dhr: no.Expiry date: n/a.Ifu reference: ifu nonsterile inst rev j.

• Brand Name: SIGMA HP SYSTEM HANDLE
• 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: 20283038
• Report Number: 1818910-2024-19999
• Device Sequence Number: 7987614
• Product Code: LXH
• UDI-Device Identifier: 10603295084174
• UDI-Public: (01)10603295084174(10)SO2044148
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 09/23/2024

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: 202499111
• Device Lot Number: SO2044148
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 11/28/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/11/2024; 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2019
• 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