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

Catalog Number	202440400
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8400440
• Report Number: 1818910-2019-86743
• Device Sequence Number: 253016
• Product Code: HWT
• UDI-Device Identifier: 10603295082996
• UDI-Public: 10603295082996
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 202440400
• Device Lot Number: B1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1