MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRIAL SZ4; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number	96-1044
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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
After the conference, the following divergences were detected: the screw in question is not holding in the femur test.Product: 961044, batch: nb68958.The screw head is damaged.Product: 961045, batch: so2031909.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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: update 30-apr-2021, the investigation was re-opened, due to device returned.Examination of the returned device confirmed, the reported event.The noted damage is attributed to a combination of wear out over the cycle life of the device.And material overload, during the usage in the field.The investigation did not establish a need for corrective action.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: the product investigation, found no evidence suspecting an error in the manufacturing or material, that would be a contributing factor in the reported allegation(s), where the lot code was provided.A manufacturing records evaluation (mre) was not performed.

• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10792590
• Report Number: 1818910-2020-24022
• Device Sequence Number: 2988424
• Product Code: LXH
• UDI-Device Identifier: 10603295234722
• UDI-Public: 10603295234722
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2020

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: 96-1044
• Device Catalogue Number: 961044
• Device Lot Number: NB68958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 03/29/2021; 04/30/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 01/11/2021; 04/09/2021; 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1