MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SIGMA INSET PATELLA CLAMP HEAD; KNEE INSTRUMENT/TRIAL

Catalog Number	966683
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
(b)(4) complaint form states that csr reported damage.The patella has a piece of the orange rubber missing.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The device associated with this reported event was not received for examination.Depuy considers the investigation closed.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.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary the device associated with this report was not returned to depuy synthes in warsaw for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.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: SIGMA INSET PATELLA CLAMP HEAD
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6913476
• Report Number: 1818910-2017-25863
• Device Sequence Number: 1408722
• Product Code: HXD
• UDI-Device Identifier: 10603295249610
• UDI-Public: 10603295249610
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2017

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: 966683
• Device Lot Number: H1105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/23/2017; 10/31/2017; 09/19/2018
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 10/25/2017; 11/24/2017; 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1