MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI INS SZ5 7MM LM/RL; KNEE TIBIAL INSERT

Catalog Number	102453507
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	10/25/2017
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
It was reported that the surgeon did a sigma hp uni on this patient and could not get the poly to lock into the tray after several attempts.Another poly was opened and locked into place immediately.
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device revealed evidence confirming the reported event of inability to assemble with the mating device.Device history review: dhr reviewed: 10 products manufactured placed into stock on 03 aug 2016.No anomalies identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP UNI INS SZ5 7MM LM/RL
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 7044232
• Report Number: 1818910-2017-50074
• Device Sequence Number: 16416922
• Product Code: HRY
• UDI-Device Identifier: 10603295002635
• UDI-Public: 10603295002635
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K070267
• 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
• Report Date (Section B): 10/25/2017

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: 102453507
• Device Lot Number: 722703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 11/19/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1