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

Model Number 2024-99-111

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Sigma partial red universal handle - the connection between the cutting blocks/jigs and handle seems loose.We understand there is supposed to be some give in the connection, but this one seems excessively loose.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> the device associated with this report was returned for analysis.Examination of the returned device revealed signs of wear and rusted areas.Functional testing showed that the device properly function, however when the devices is unlocked the lever is loose.The reported complaint was confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot
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> 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.

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.

• Brand Name: SIGMA HP SYSTEM HANDLE
• Type of Device: 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12562153
• MDR Text Key: 274263353
• Report Number: 1818910-2021-21691
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295084174
• UDI-Public: 10603295084174
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 2024-99-111
• Device Catalogue Number: 202499111
• Device Lot Number: A0609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 11/03/2021; 12/21/2021
• Supplement Dates FDA Received: 11/14/2021; 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1