MAUDE Adverse Event Report: MEDSHAPE, INC. EF1; WIRE, 2.0 X 450MM, OLIVE, BAYONET TIP

Catalog Number	DNE-6000-201
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during this case the doctor reported that he could not advance the smooth or olive ef1 wires due to them being extremely dull.This added at least an extra 20 minutes to the case as they needed to be forced into the bone every time they were implanted.Was investigated where it was found that there was an issue with ef1 2.0 x 450mm wire (dne-6000-200) that was found dull and had difficulty using intra-operatively.The current complaint also includes ef1 2.0 x 450mm wire (dne-6000-201) which is a similarly used wire and has the same failure mode.Per 7000.010, complaints which are similar in sku, failure mode, and usage to a complaint that has already been investigated do not need to be investigated.
Event or Problem Description
It was reported that during this case the doctor reported that he could not advance the smooth or olive ef1 wires due to them being extremely dull.This added at least an extra 20 minutes to the case as they needed to be forced into the bone every time they were implanted.

• Brand Name: EF1
• Common Device Name: WIRE, 2.0 X 450MM, OLIVE, BAYONET TIP
• 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: 23824375
• Report Number: 3007593722-2025-00024
• Device Sequence Number: 4993250
• Product Code: KTT
• UDI-Device Identifier: 00810028396036
• UDI-Public: 00810028396036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DNE-6000-201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/16/2025
• 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