MAUDE Adverse Event Report: NEWDEAL SAS TTC PLATE - 9 HOLES - RIGHT; N/A

Catalog Number 181004SND

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

On (b)(6) 2019, a sales representative received a call from a physician who reported an issue with a tcc plate (9 holes-right / product id (b)(6)).Two of the calcaneus screws backed out as well as the locking caps.The physician will see the patient again to determine what additional actions are required as far as if a removal is needed.

Manufacturer Narrative

The device was not returned for evaluation therefore the failure analysis to identify to the end users experience could not be determined.Dhr review cannot be performed at this time.The reported complaint was not confirmed.The root cause cannot be determined.Device identifier : (b)(4).

Manufacturer Narrative

Additional information: product implanted on (b)(6) 2018 due to talus avascular necrosis.On (b)(6) 2019, during a follow up visit, the patient presented with wound dehiscence and swelling of foot, and a plain radiograph showed the ttc plate in position with locking washers in soft tissue out of plate at distal most three holes.The patient was compliant with postoperative protocol and reported no traumatic or contributing event prior to the discovery of this issue.On (b)(6) 2019, surgeon removed loose locking washers in office through wound dehiscence.Patient underwent wound treatment, continued with complementary and alternative medicine boot immobilization.On (b)(6) 2019, the product was explanted.

• Brand Name: TTC PLATE - 9 HOLES - RIGHT
• Type of Device: N/A
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 8491093
• MDR Text Key: 141190192
• Report Number: 9615741-2019-00006
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K073375
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 181004SND
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1