MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CAS LIGAMENT TENSOR SIZE 4-XF; SURGICAL ACCESSORIES : ALIGNMENT DEVICES

Catalog Number	129901081
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was noted that the instrument does not fully compress and spring becomes caught between the upper and lower plates upon compression.This causes one side of the upper plate to sit higher than the other until enough force is applied to 'click' the spring down.On visual inspection, the springs appear to be warped.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
B)(4).Investigation summary = > examination of the device confirmed the failure mode as reported.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > the dhr was reviewed for this lot.There were no nonconformances or other issues noted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CAS LIGAMENT TENSOR SIZE 4-XF
• Common Device Name: SURGICAL ACCESSORIES : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7937943
• Report Number: 1818910-2018-71405
• Device Sequence Number: 1998665
• Product Code: NJL
• UDI-Device Identifier: 10603295027089
• UDI-Public: 10603295027089
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2018

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: 129901081
• Device Lot Number: AB3729344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 06/12/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/11/2018; 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1