MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EXTERNAL ALIGN ANKLE CLAMP; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	249049000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: this device was not returned for evaluation but based on the received photographs the complaint can be confirmed.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
The lcs ankle clamp black up rod, has the sleeve stuck in place.Unable to insert and secure the proximal rod that attaches the tibial cutting block into the ankle clamp.

• Brand Name: EXTERNAL ALIGN ANKLE CLAMP
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8086118
• Report Number: 1818910-2018-75933
• Device Sequence Number: 295747
• Product Code: HXD
• UDI-Device Identifier: 10603295125891
• UDI-Public: 10603295125891
• 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
• Report Date (Section B): 11/16/2018

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: 249049000
• Device Lot Number: J0300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1