MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 LCS HP IM PLATE 4 DEG RT; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	950503013
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Total knee replacement on (b)(6) 2018.The doctor was setting up the rod that attaches to the block and realized that the ap block wouldn¿t lock correctly.When we pulled the block apart we notice the plate and the rod had broken away from it self, which is why he couldn¿t lock the two together.Action taken: open up another tray of instruments to get another rod, call ops who sent another rod in to replace so we had all the correct instruments for all five knees on that day.No delay to procedure.No ae to patient.
Additional Manufacturer Narrative
(b)(4).The instrument associated with this report was not returned.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.

• Brand Name: LCS HP IM PLATE 4 DEG RT
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7312845
• Report Number: 1818910-2018-54529
• Device Sequence Number: 16169264
• Product Code: LXH
• UDI-Device Identifier: 10603295230069
• UDI-Public: 10603295230069
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: 950503013
• Device Lot Number: J0309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1