MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 FEM/TIB EXTRAC 11X7 3/4 IN; KNEE INSTRUMENT : EXTRACTION INSTRUMENTS

Catalog Number	242102000
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
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
Fem/tib extractor handle cracked and the tip of the instrument broke off while removing a femoral component.All pieces were retrieved and there was no additional time added to the surgery.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the reported event.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: FEM/TIB EXTRAC 11X7 3/4 IN
• Common Device Name: KNEE INSTRUMENT : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7781320
• Report Number: 1818910-2018-66600
• Device Sequence Number: 13747062
• Product Code: HWB
• UDI-Device Identifier: 10603295122722
• UDI-Public: 10603295122722
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: 242102000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 08/20/2018
• Patient Sequence Number: 1