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

Model Number	25102211E
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The axial pin inserter/extractor cross threaded with an axial pin and became damaged.
Additional 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 or Problem Description
The axial pin inserter/extractor cross threaded with an axial pin and became damaged.

• Brand Name: AXIAL PIN INSERTER/EXTRACTOR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• MDR Report Key: 9633778
• Report Number: 3013450937-2020-00007
• Device Sequence Number: 3529452
• Product Code: KRP
• UDI-Device Identifier: B27825102211E0
• UDI-Public: B27825102211E0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 25102211E
• Device Catalogue Number: 25102211E
• Device Lot Number: 1488408
• Initial Date Received by Manufacturer: 01/01/2020
• Supplement Date Received by Manufacturer: 01/01/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR