MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIBIAL STYLUS; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number 202440400

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: examination of the returned device found the locking mechanism will not lock.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.Functional examination of the submitted hp uni tibial stylus found locking mechanism to not properly lock.Visual examination of the device reveals wear on the stylus arm component teeth.The wear on the teeth is from repetitive ratcheting over time.There is no visual evidence of handling damage or manufacturing defects.The non-functional locking mechanism is due to wear on the stylus arm component.The device is old (mfg 2009), worn out and reached the end of its¿ useful life.The root caused is attributed to device wear form normal use and servicing.No corrective action is being pursued based on the root cause of device wear form normal use and servicing complaint trends will be monitored by post market surveillance through sep-419.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.

Event Description

The instruments were reported for unknown reason.In-house engineering evaluation: examination of the returned device found the locking mechanism will not lock.

• Brand Name: SIGMA HP UNI TIBIAL STYLUS
• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8400440
• MDR Text Key: 138146905
• Report Number: 1818910-2019-86743
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295082996
• UDI-Public: 10603295082996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 202440400
• Device Lot Number: B1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Date Manufacturer Received: 02/21/2019
• Date Device Manufactured: 10/15/2009
• 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