MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ4; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6024
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
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
It was reported that 1, box hair found inside the shrink-wrap cover.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > the device associated with this report was returned.After visual examination, allegation is confirmed.A hair was observed between the carton package and shrink wrap plastic cover.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 = > a manufacturing record evaluation (nc search) was performed for the finished device 866024, d21122836, and no non-conformances / manufacturing irregularities were identified.Device history review = > a manufacturing record evaluation was performed for the finished device (866024/d21122836) product and lot numbers, and no non-conformances were identified.H10 additional narrative: added: d9 corrected: h3.

• Brand Name: PFC SIGMA MOD TIB TRAY CEM SZ4
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14101477
• Report Number: 1818910-2022-06628
• Device Sequence Number: 4805190
• Product Code: JWH
• UDI-Device Identifier: 10603295216797
• UDI-Public: 10603295216797
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 86-6024
• Device Catalogue Number: 866024
• Device Lot Number: D21122836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown