MAUDE Adverse Event Report: MEDSHAPE, INC DYNANAIL TTC FUSION NAIL

Model Number 1200-01-1022

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the dynanail allegedly broke in a patient and the patient experienced pain where the break occured.On 31oct2022, (b)(4), djo f&a sales representative, notified (b)(6), regional account coordinator, of a 1200-01-1022 (dynanail, 10 x 220mm) that broke in a patient.This was observed during follow up review, in which the patient reported pain in an area corresponding to where the nail breakage occurred.He stated that the implant case was performed by dr.(b)(6) on (b)(6) 2022 at (b)(6) hospital on a 62 year old male patient (dob: (b)(6) 1960).The date of the explant surgery has not yet been scheduled.(b)(4) stated dr.(b)(6) does not have any information on why the 1200-01-1022 broke post-operatively and that the "nail (1200-01-1022) snapped at ankle joint." he provided x-ray images showing the broken nail.In follow up email with (b)(6) , (b)(4) stated he was present at the case on (b)(6) 2022 when the 1200-01-1022 was implanted and that dr.(b)(6) used the correct technique.The removal surgery has yet to be scheduled and a request has been made to have the broken explanted nail returned for further investigation.A supplemental mdr report will be filed for complaint (b)(4) when all necessary information has been obtained and the complaint investigation has been completed.

Event Description

It was reported that the dynanail allegedly broke in a patient and the patient experienced pain where the break occured.

Manufacturer Narrative

On (b)(6) 2022, the broken dynanail device was successfully removed at the (b)(6) clinic by dr.(b)(6).The explanted nail was returned, indicating fracture of both the outer body and compressive element.On (b)(6) 2022, a call was held with sales representative (b)(6).Dr.(b)(6) stated to (b)(6) during the removal case that during the rehabilitation period following surgery the patient had reported pain immediately after falling while stepping off a ladder.A subsequent call was held with dr.(b)(6) on (b)(6) 2022, in which he stated that post-operative patient reviews prior to the fall incident were yielding progression towards full bone union, however immediately after the reported fall pain was reported and imaging identified full breakage of the dynanail device.From review with dr.(b)(6), the intended bone fusion was nearing 100%, however the patient fall was likely the root cause of the complete fracture of the dynanail outer body and compressive element.Complaint history review in the past 12 months shows 1 previous reported complaint for dynanail ttc device breakage (reference complaint: (b)(4) no device deficiency).Based on the extremely low complaint rate for this failure mode of dynanail breakage occurring in the past year (b)(4) 2 occurrences / approximately 915 dynanail devices implanted), and the root cause determined to be patient injury / non-compliance during the rehabilitation period, no investigation or corrective action is necessary at this time as there is no clear device deficiency or non-conformance.The dynanail ttc packaging inserts (mk-10062) provides adequate warnings that this failure can occur as the device is intended to facilitate bone fusion and not support weight bearing and that physical activities must be restricted until there is confirmation of bony union.Future complaints of this nature will be monitored to determine if any additional actions may be necessary.

• Brand Name: DYNANAIL TTC FUSION NAIL
• Type of Device: DYNANAIL TTC FUSION NAIL
• Manufacturer (Section D): MEDSHAPE, INC; 1575 northside dr nw; suite 440; atlanta GA 30318
• Manufacturer Contact: justin lovelace ; 1575 northside dr nw; suite 440; atlanta, GA 30318
• MDR Report Key: 15820759
• MDR Text Key: 303900591
• Report Number: 3007593722-2022-00004
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1200-01-1022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 104 KG