MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0015
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
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
Customer is reporting difficulties while removing the cover of sterile implant packages.These issues are not limited to a certain implant type.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : examination of the returned device confirmed the reported event.No evidence was found indicating product error was a contributing factor.The device was manufactured on 07-jan-2020.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : product code 960015, work order (b)(4) was manufactured 07-jan-2020.(b)(4) parts manufactured per specification and all raw materials met specification.(b)(4) part was scrapped from this lot.There is no correlation with the complaint failure mode.Scrap: a173 (pits).The expiry date for this lot was 31-dec-2024.There was 1 ncs associated with this lot.Nr-(b)(4) ¿ drag bowls validation documentation error.This nc relates to the drag process in the femoral value stream.In the validation documentation a table from the suppliers with recommended parameters was inverted.This nc does not relate to the failure mode of the complaint.The ifu ref was (b)(4).No reprocessing associated with this lot.Packaging seal test passed.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9792753
• Report Number: 1818910-2020-06906
• Device Sequence Number: 14096930
• Product Code: JWH
• UDI-Device Identifier: 10603295232049
• UDI-Public: 10603295232049
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K943462
• 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
• Report Date (Section B): 02/14/2020

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: 96-0015
• Device Catalogue Number: 960015
• Device Lot Number: 9387941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1