MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ANTEVERSION OSTEOTOME SM; HIP INSTRUMENTS : CUTTING INSTRUMENTS

Model Number 2002-31-000

Device Problems Dull, Blunt (2407); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

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

After the conference, the following divergences were detected: code: 200231000, batch: cv0410, blunt damaged part.Code: 253081000, lot: j0110 chipped head.

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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : the instrument associated with this report was not returned, but a photo was provided confirming the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.H10 additional narrative: added: b5, e1 (facility name).

Event Description

Additional information received stated that upon review of the photographs provided, it was found that the trial ball exhibited deep scratches and nicks, and the cutting instrument exhibited deep nicks out of the cutting edges.

• Brand Name: ANTEVERSION OSTEOTOME SM
• Type of Device: HIP INSTRUMENTS : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10310804
• MDR Text Key: 202235087
• Report Number: 1818910-2020-16602
• Device Sequence Number: 1
• Product Code: HWM
• UDI-Device Identifier: 10603295080794
• UDI-Public: 10603295080794
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2002-31-000
• Device Catalogue Number: 200231000
• Device Lot Number: CV0410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1