MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. K-WIRE 1.1MM, SMOOTH, SINGLE TROCAR; 1.1MM HCS K-WIRE SMOOTH

Model Number	EX01-0028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The guide wire can also be deformed during a transition through a joint in which movement of the joint during fixation, or pin deflection crossing the joint space, creates a slight change in direction.This change of direction can hamper smooth passage of the drill bit over the guide pin and can erode the pin, creating a stress riser in the pin that results in breakage.
Event or Problem Description
Two 1.1mm kwires broke off during a hand surgery.The doctor mentioned that they broke within the bone.The bone in this area is very hard bone.One broken wire appears to be angled to a point that when the fastener was inserted in pushed against they wire causing the breakage.
Additional Manufacturer Narrative
Udi related data quality updates, product information update, initial reporter updates, & report source update: this follow-up report includes the addition of the brand name, model number, and full udi, which were missing from the initial report.This report was updated to include corrected 510(k).This report indicates that the report product is for single use.This report specifies that this is not a combination product.Additionally, this report updates the initial reporter information to the physician who initially reported the issue and includes the report source of how the issue became known by osteocentric technologies, inc.

• Brand Name: K-WIRE 1.1MM, SMOOTH, SINGLE TROCAR
• Common Device Name: 1.1MM HCS K-WIRE SMOOTH
• Manufacturer (Section D): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• Manufacturer (Section G): OSTEOCENTRIC TECHNOLOGIES, INC.; osteocentric technologies, inc; 75 w 300 n; logan UT 84321
• MDR Report Key: 18288438
• Report Number: 3011656326-2023-00006
• Device Sequence Number: 6696810
• Product Code: HTY
• UDI-Device Identifier: 00850015496264
• UDI-Public: (01)00850015496264
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K200259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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 Model Number: EX01-0028
• Device Catalogue Number: EX01-0028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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