MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LTSZ2.5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0008
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
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 inner sterile packaging could not be lifted out of the outer sterile packaging at the tab because it was stuck.Another product was available and used without issues.No surgical delay, no adverse patient consequences.
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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : examination of the returned device could not confirm the reported event.No evidence was found indicating product error was a contributing factor.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : the device history record (dhr) was reviewed.Product code 960008, lot number d19081761 was manufactured on 23-aug-2019.(b)(4) pcs parts were manufactured per specification and all raw material met specification.No non-conformances / manufacturing irregularities were identified.The expiry date is 31-jul-2024.Ifu reference no.Is ifu-0902-00-252.

• 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: 12233127
• Report Number: 1818910-2021-16152
• Device Sequence Number: 19749895
• Product Code: JWH
• UDI-Device Identifier: 10603295232001
• UDI-Public: 10603295232001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2021

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: 96-0008
• Device Catalogue Number: 960008
• Device Lot Number: D19081761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/13/2021; 10/27/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/19/2021; 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1