MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US NEUFLEX PIP IMPLANT SZ 1; NEUFLEX IMPLANT : FINGER IMPLANT

Catalog Number 123310000

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/03/2018

Event Type  Injury  

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

On (b)(6) a neuflex joint revision was done due to a broken neuflex implant.The old neuflex was removed and the same size was put in.I do not have access to the broken implant.I do not have patient information and i do not know when the original surgery took place.The reason for the delay of report is that i typically do not do joint cases and wasn't familiar with the complaint process.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: NEUFLEX PIP IMPLANT SZ 1
• Type of Device: NEUFLEX IMPLANT : FINGER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 8000046
• MDR Text Key: 124838951
• Report Number: 1818910-2018-73389
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 10603295017899
• UDI-Public: 10603295017899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Device Operator: Health Professional
• Device Catalogue Number: 123310000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1