MAUDE Adverse Event Report: CARTIHEAL LTD. INSTRUMENT KIT DISPOSABLE ARAGONITE; INSTRUMENTS DESIGNED FOR PRESS-FIT OSTEOCHONDRAL IMPLANTS

Catalog Number	MINI-DS
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during surgery, the k-wire of the aragonite disposable instrument kit broke when removing the drill bit and drill sleeve.The surgeon admitted that she ¿let her hand drop¿ too much and lost her perpendicularity.The broken piece was easily removed using the pin-driver.The procedure was resumed without incident, after a non-significant delay, using a back-up product.Following the replacement of the k-wire, the surgeon maintained proper perpendicularity for the remainder of the surgery and the case was completed without incident.Patient was not harmed.The surgeon was extremely satisfied with the surgical outcome.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was not made available to the designated complaint unit for evaluation.A review of production records showed that there is no indication to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review revealed that this is the first incident of this nature.A risk management review found that the reported failure and/or harm was documented appropriately; there are no indications to suggest that the anticipated risk is not adequate.According to the reported event, the surgeon ¿let her hand drop,¿ which caused a loss of perpendicularity.Based on what occurred during the removal of the drill bit and drill sleeve, the most probable root cause is an unintended use error.Factors that contribute to a k-wire breakage include an unintended deviation in surgical technique, loss of perpendicular alignment during drilling, and the application of uneven or off-axis force while removing the drill bit and drill sleeve.Considering that the surgeon acknowledged the use error, successfully used an additional k-wire, and maintained proper perpendicularity for the remainder of the surgery, the need for corrective action is not indicated.

• Brand Name: INSTRUMENT KIT DISPOSABLE ARAGONITE
• Common Device Name: INSTRUMENTS DESIGNED FOR PRESS-FIT OSTEOCHONDRAL IMPLANTS
• Manufacturer (Section D): CARTIHEAL LTD.; 17 atir yeda street; kfar saba central 44643 13; IS 4464313
• Manufacturer (Section G): CARTIHEAL LTD.; 17 atir yeda street; kfar saba central 44643 13; IS 4464313
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24093018
• Report Number: 3013881076-2026-00003
• Device Sequence Number: 10259602
• Product Code: QBO
• UDI-Device Identifier: 07290019087045
• UDI-Public: 7290019087045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: MINI-DS
• Device Lot Number: 0008
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2024
• 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
• Patient Age: 18 YR
• Patient Sex: Female