MAUDE Adverse Event Report: MEDSHAPE, INC. EF1; UNIVERSAL JOINTS

Catalog Number	DNE-9000-UJ
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
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
Complaint: device broke post op.
Additional Manufacturer Narrative
It was reported that an ef1 case showing some of the universal joints disconnected.Follow up with confirmed no patient harm related to the complaint.Initially, it was presumed the universal joint failure was due to non-compliance of the patient being weight bearing prematurely.However, in response to this and additional similar complaints, a cross-functional meeting was held on (b)(6) 2025 to further discuss the universal joint disconnection issue.During that meeting, the investigation team identified a subset of the universal joint population that can have a situation in which the short pins which are press fit to hold the universal joint together can become loose and dislodge.In this subset the universal joints can become disconnected.For the purpose of mdr reporting, the (b)(6) 2025 meeting serves as awareness this complaint was more associated with a component issue and less associated with patient non-compliance.As an outcome from the meeting, a health hazard evaluation was initiated to assess patient impact and the decision was made to open a capa to document and further investigate the cause and identify corrective action.

• Brand Name: EF1
• Common Device Name: UNIVERSAL JOINTS
• 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: 21931581
• Report Number: 3007593722-2025-00005
• Device Sequence Number: 8651272
• Product Code: KTT
• UDI-Device Identifier: 00810028397101
• UDI-Public: 00810028397101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/06/2025

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-9000-UJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown