MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; BIOGRIP PROXIMAL TIBIA, 87MM

Model Number	PT-20000-02M
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in process.The device will not be returned.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
It was reported that sutures tore intraoperatively on the anterior/posterior holes of an eleos proximal tibia.Dr.(b)(6) was using ethibond 5 sutures.The surgeon brought the sutures anteriorly after exiting the posterior suture holes, which resulted in the sutures tearing.In order to successfully complete the surgery, dr.(b)(6) doubled up on the sutures.No additional information regarding this event was obtained.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the sutures tearing intraoperatively on the suture holes of the proximal tibia was due to the device design.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 114: operational problem identified.H6: investigation conclusions code updated to 12: cause traced to device design.H10: additional narratives/data.
Event or Problem Description
It was reported that sutures tore intraoperatively on the anterior/posterior holes of an eleos proximal tibia.Dr.(b)(6) was using ethibond 5 sutures.The surgeon brought the sutures anteriorly after exiting the posterior suture holes, which resulted in the sutures tearing.In order to successfully complete the surgery, dr.(b)(6) doubled up on the sutures.No additional information regarding this event was obtained.

• Brand Name: ELEOS
• Common Device Name: BIOGRIP PROXIMAL TIBIA, 87MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC.; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 13443189
• Report Number: 3013450937-2022-00030
• Device Sequence Number: 11273990
• Product Code: KRO
• UDI-Device Identifier: B278PT2000002M0
• UDI-Public: B278PT2000002M0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: PT-20000-02M
• Device Catalogue Number: PT-20000-02M
• Device Lot Number: 88658RR-031
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ETHIBOND 5 SUTURES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male