MAUDE Adverse Event Report: MEDSHAPE, INC. EF1; NUT - 10MM

Catalog Number	DNE-6000-036
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to post-op x-ray showed a broken 5mm half pin in the tibia.Doctor explained that the most proximal half pin had become detached from the frame and the patient had subsequently broken the most distal tibial half pin.Also, some of the nuts were rounded and cross threaded.He commented that the metal was too soft.
Additional Manufacturer Narrative
It was reported that the post-op x-ray showed a broken 5mm half pin the tibia.Doctor explained that the most procimal half pin had become detached from the frame and patient had subsequently broken the most distal tibial half pin.Also, someof the nuts were rounded and cross threaded.He commented that the metal was too soft.The investigation confirmed a total of six (6) 10mm nut (dne-6000-036) were cold welding/galling to the wire fixation bolt and half pin fixation bolt.One (1) of the 10mm nuts was removed from a wire fixation bolt and additional material was observed withing the bolt's threads indicating that galling had occurred between the nut and bolt.This complaint was reported after a surgeon removed a circular frame from a patient who fell down the stairs and broke a half pin (dne-518045).The half pin broke because the forces applied during the fall exceeded the half pin's clinically relevant forces.Car-00916 has been opened to further investigate the 10mm nut cold welding/galling, this also list all the components returned.No similar complaints were identified when the complaints for the rolling year ((b)(6) 2024 through (b)(6) 2025) was reviewed for issues concerning the dne-6000-036, 10mm nut for the external fixation systems.The lot is unknown.The ef1 circular frame surgical technique mkt-fa24-0029 rev a was reviewed.The 10mm nuts are used to secure the multiple components (i.E.Fixation bolts and posts) to the frame.The ef1 risk management document risk-fa007-0001 rev a (medshape ed-50572 rev 00) was reviewed.The included hazard analysis was written using severity, occurrence, and detection under the medshape qms.This risk document does not cover the cold welding/galling, it does associate a risk to fasteners (nuts, bolts) breaking or thread stripping with a patient severity 1, device severity 1, occurrence 1 and detection 1.For the cold welding/ galling it does not affect the patient, it affects the surgeon during removal.A car-00916 has been opened.

• Brand Name: EF1
• Common Device Name: NUT - 10MM
• 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: stacey bonnell ; 1575 northside dr nw; suite 440; atlanta, GA 30318 ; 4847879764
• MDR Report Key: 21579854
• Report Number: 3007593722-2025-00003
• Device Sequence Number: 18505846
• Product Code: KTT
• UDI-Device Identifier: 00810028397217
• UDI-Public: 00810028397217
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/07/2025

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: DNE-6000-036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 07/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DNE-1000-WFB LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female