MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS FEMORAL IMPACTOR; INSTRUMENT, KNEE

Lot Number	1488407
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and did not indicate any nonconformance that would have led to this malfunction.The instrument was returned for further analysis and this report will be supplemented when further information is made available.
Event or Problem Description
During a training event it was identified that a reusable femoral impactor was missing the two screws needed to hold the driver head to the handle of the impactor.
Additional Manufacturer Narrative
The device history record was reviewed and did not indicate any nonconformance that would have led to this malfunction.The instrument was returned for further analysis and this report will be supplemented when further information is made available.The contract manufacturer evaluated the returned instrument and found visible wear, which is consistent for normal use of the instrument.Also, the appropriate screws were able to be threaded into the screw holes on the handle.Additionally, they highlighted that cleaning and handling instructions state, "where applicable, multi-component instruments should be disassembled for appropriate cleaning".The contract manufacturer concluded that the cause of the missing screws was likely due to improper disassembly/reassembly during cleaning/reprocessing.This complaint involved a reusable instrument whose life span depends on the method in which it is used, the duration of use, and its handling between uses.Additionally, the damaged instrument made it into the field because the central distribution center was unaware of the required subcomponents for this instrument.Further inspection criteria were provided to the central distribution center to prevent the reoccurrence of this complaint.The root cause for the femoral impactor missing its screws could not be determined but could have potentially been attributed to increased handling use or improper disassembly/reassembly during cleaning reprocessing.Based upon the device history review and evaluation of the returned component it was concluded that the instrument failure could not be attributed to the manufacturing of the eleos component.
Event or Problem Description
During a training event it was identified that a reusable femoral impactor was missing the two screws needed to hold the driver head to the handle of the impactor.

• Brand Name: ELEOS FEMORAL IMPACTOR
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8722302
• Report Number: 3013450937-2019-00029
• Device Sequence Number: 11393772
• Product Code: KRO
• UDI-Device Identifier: B27825107600E0
• UDI-Public: B27825107600E0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: Other
• Device Lot Number: 1488407
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1