MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN FINGER IMPLANT

Catalog Number UNK FINGER

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient initiated complaint received.Received a voicemail from patient informing about the broken implants of her right hand.She said the middle finger on her right hand is slightly off while the ring finger is completely off this was implanted on (b)(6) 2012.Unable to provide the part and lot number of the products implanted.Currently the patient is wearing splints, she already have 3 splints and waiting for the last one.Patient said, she already spent (b)(6) of the splints alone.Her surgeon wasn't sure on what to do about her case.Apologized and empathized to patient.Explained to her about the authorization letter, this will be sent through mail.There is no revision reported at this time.Doi: (b)(6) 2012 : dor: not revised (right hand).Patient is bilateral, please see (b)(4) (left hand).

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.The investigation could not draw any conclusions regarding the reported event.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: UNKNOWN FINGER IMPLANT
• Type of Device: FINGER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7362026
• MDR Text Key: 103408991
• Report Number: 1818910-2018-55886
• Device Sequence Number: 1
• Product Code: KYJ
• 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
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FINGER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2018
• 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