MAUDE Adverse Event Report: ONKOS SURGICAL AXIAL PIN INSERTER/EXTRACTOR; PROSTHESIS, KNEE

Model Number 25102211E

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed and found that the component involved met specification.The damaged instrument was requested to be returned for further analysis.Should additional information be obtained the report will be supplemented.

Event Description

The axial pin inserter/extractor cross threaded with an axial pin and became damaged.

Manufacturer Narrative

The device history record was reviewed and found that the component involved met specification.The damaged instrument was returned for further analysis and it was confirmed that the threads had cross threaded.Interview with the sales representative found that the surgeon attempted to keep the incision very minimal, which did not grant them easy trajectory for the instrument.The sales representative reported that the instrument had been inserted into the pin on an angle, thus causing the threads to cross and the instrument to become damaged.Additionally, this instrument is reusable, and its life span depends on the method in which it is used, the duration of use, and its handling between uses.Ultimately, based upon the device history record and interview with the sales representative it was concluded that the instrument failure could not be attributed to the manufacturing of the eleos component.

Event Description

The axial pin inserter/extractor cross threaded with an axial pin and became damaged.

• Brand Name: AXIAL PIN INSERTER/EXTRACTOR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• MDR Report Key: 9633778
• MDR Text Key: 183975314
• Report Number: 3013450937-2020-00007
• Device Sequence Number: 1
• Product Code: KRP
• UDI-Device Identifier: B27825102211E0
• UDI-Public: B27825102211E0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25102211E
• Device Catalogue Number: 25102211E
• Device Lot Number: 1488408
• Date Manufacturer Received: 01/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR