MAUDE Adverse Event Report: DEPUY IRELAND 961610 ADV+ CUTTING GUIDE RT; EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number	212862110
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
Fixation pin became lodged in anatomic resection guide.No user error, unable to advance or back up pin.Surgeon had to cut pin in order to continue using cut guide.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: 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: ADV+ CUTTING GUIDE RT
• Common Device Name: EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• MDR Report Key: 7776219
• Report Number: 1818910-2018-66337
• Device Sequence Number: 11153113
• Product Code: LXH
• UDI-Device Identifier: 10603295089810
• UDI-Public: 10603295089810
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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: 212862110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 08/13/2018
• 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