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

Model Number 96-6315

Device Problems Material Deformation (2976); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

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 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*.

Manufacturer Narrative

Product complaint #
=
>(b)(6).Investigation summary
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> 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.

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.

• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10763239
• MDR Text Key: 213898206
• Report Number: 1818910-2020-23664
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295247791
• UDI-Public: 10603295247791
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/28/2020; 11/20/2020
• Supplement Dates FDA Received: 11/07/2020; 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1