MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US IM INITIATOR SIZED; HIP INSTRUMENTS : INSERTION DEVICES

Model Number 2001-80-501

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

After checking, the following divergence was detected: code: 253151000 lot in n.F: n72697 (it presents splinters).Code: l20504 lot in n.F: 9799167 (cracked cover).

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.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the instrument associated with this report was not returned.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.

• Brand Name: IM INITIATOR SIZED
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10310836
• MDR Text Key: 209160968
• Report Number: 1818910-2020-16607
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295080145
• UDI-Public: 10603295080145
• 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

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2001-80-501
• Device Catalogue Number: 200180501
• Device Lot Number: SO2029511
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/12/2020; 08/14/2020
• Supplement Dates FDA Received: 08/12/2020; 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1