MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 3 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-23-008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/11/2020
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
Broken poly of insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿ added: description of event or problem.
Event or Problem Description
1.Was the event happen during primary surgery or revision surgery.Primary.2.It is stated in the event description that "was surgery delayed due to the reported event? no.If yes, number of minutes: 3 min," can you please clarify what you have stated for the duration of delay is it 3 days or 3 mins? 3 min.3.Can you please provide the reason why the poly insert broke? due to the nature of the reported event, and in accordance with our procedures, we are required to request the following information to assist in the investigation.Please could you let me know if any/none of this information is available: patient demographics the following are the types of patient demographics we require: relevant comorbidities, date of implantation ,(b)(6)2020.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: examination of the returned device did not confirm the device was broken, but did confirm deformations present on the tab.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.

• Brand Name: SIGMA STAB GVF INS 3 8MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10080380
• Report Number: 1818910-2020-12458
• Device Sequence Number: 3300096
• Product Code: JWH
• UDI-Device Identifier: 10603295064244
• UDI-Public: 10603295064244
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2020

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 Model Number: 1581-23-008
• Device Catalogue Number: 158123008
• Device Lot Number: D18121025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/14/2020; 06/18/2020; 08/04/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/11/2020; 06/23/2020; 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1