MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SIGMA HP DIS FEM ALIGN GUIDE; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	950501234
Medical Device Problem Codes	Device-Device Incompatibility (2919); Naturally Worn (2988)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
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
Portion of femoral cutting guide is worn and doesn¿t hold guide together and the piece dropped on the floor.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the investigation identified the device is unable to assemble with mating device.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.Added: concomitant medical products.Corrected: device evaluated by mfr.

• Brand Name: SIGMA HP DIS FEM ALIGN GUIDE
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8276913
• Report Number: 1818910-2019-82234
• Device Sequence Number: 11092462
• Product Code: HWT
• UDI-Device Identifier: 10603295225393
• UDI-Public: 10603295225393
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/07/2019

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: 950501234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/05/2019
• 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