MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 INTRAMED TIB ALIGNMENT DE; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number	96-6315
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
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
It was reported that upon setting up for distal femoral replacement the part of tibial cutting jig would not work.Another tray had to be opened for the case.This piece has some rough areas and will not glide properly.Sales rep also felt that the metal piece that allows adjustment will not allow you to press it for smooth adjustment.This did not delay the case, they had another one to open.Nobody was injured by damaged piece, and i am returning.I see no lot number just 204*.
Additional Manufacturer Narrative
Product complaint # = >(b)(6).Investigation summary = > examination of the returned device could not confirm the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Corrected: h3.
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.

• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10763239
• Report Number: 1818910-2020-23664
• Device Sequence Number: 3318147
• Product Code: HWT
• UDI-Device Identifier: 10603295247791
• UDI-Public: 10603295247791
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2020

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: 96-6315
• Device Catalogue Number: 966315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 11/20/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/07/2020; 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1