MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL, 10 X 220MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	1200-01-1022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 4/9 dr removed the above nail due to the patient have severe pain in his tibia above the nail.There was no stress fracture or any defect in the bone visible via xray so dr flint did not know what was causing the pain.Dr was not concerned with the effectiveness of our nail as the ttc joints had healed perfectly.This nail was put in approximately 12 months ago.Dr decided to span the entire tibia with a supra patellar tibial nail from stryker after removing ours.Implants were not able to be obtained as hospital policy is to discard.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 or Problem Description
On 4/9 dr removed the above nail due to the patient have severe pain in his tibia above the nail.There was no stress fracture or any defect in the bone visible via xray so dr flint did not know what was causing the pain.Dr was not concerned with the effectiveness of our nail as the ttc joints had healed perfectly.This nail was put in approximately 12 months ago.Dr decided to span the entire tibia with a supra patellar tibial nail from stryker after removing ours.Implants were not able to be obtained as hospital policy is to discard.
Additional Manufacturer Narrative
See a2 and h11 in conclusion, no root cause could be determined as to why the patient had reported pain above the tibia despite the 10x220mm dynanail device fully fusing the ttc joint and not having any breakage or visual defects.Device history record review shows that the associated finished good and raw materials used were 100% conforming to specification and due to lack of the originally implanted nail (discarded by facility) further testing / evaluation cannot be performed.Surgeon feedback and operative notes do not suggest that the pain was related to patient non-compliance to protocols, injury, or illness, further evidenced by the successful ttc joint fusion.Despite this patient pain and dynanail removal, a new nail device and screws were implanted successfully from a different company.While no root cause could be identified, complaint history review does not suggest a recurrence for this failure mode.For the above reasons, no further actions or capa are necessary in response to this complaint.Future similar reports shall be monitored and assessed per 7000.010 global complaint handling process.

• Brand Name: DYNANAIL, 10 X 220MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside dr nw; suite 440; atlanta GA 30318
• Manufacturer (Section G): MEDSHAPE, INC.; 1575 northside dr nw; suite 440; atlanta GA 30318
• Manufacturer Contact: justin lovelace ; 1575 northside dr nw; suite 440; atlanta, GA 30318 ; 4805161552
• MDR Report Key: 19235504
• Report Number: 3007593722-2024-00005
• Device Sequence Number: 8034879
• Product Code: HSB
• UDI-Device Identifier: M97012000110220
• UDI-Public: M97012000110220
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: D155711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1200-01-1022
• Device Lot Number: D0086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Male