MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP IM TIBIA JIG; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	950501203
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
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
Blue knob on the front wasn't locking into place when adjusting the level of resection.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device was received.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

• Brand Name: HP IM TIBIA JIG
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7927329
• Report Number: 1818910-2018-71068
• Device Sequence Number: 16506288
• Product Code: NJL
• UDI-Device Identifier: 10603295225119
• UDI-Public: 10603295225119
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• 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): 09/12/2018

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: 950501203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR