MAUDE Adverse Event Report: K2M, INC. AXIAL ROD CONNECTOR, OPEN-CLOSED; SIZE 5.5/6.0 - 5.5/6.0; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2901-86055MF
Medical Device Problem Codes	Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the set screw would not thread into two everest axial rod-to-rod connectors during product inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.This report captures the second of the two devices.
Event or Problem Description
A company representative reported that the set screw would not thread into two everest axial rod-to-rod connectors during product inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.This report captures the second of the two devices.
Additional Manufacturer Narrative
The device was inspected and no visual non-conformance was observed.Functional inspection was performed the connectors failed the functional test on the closed end but passed on the open end, when tested with a set screw.A ct scan of the part in question showed a slight offset of the minor and major diameter which would lead to having a binding thread.As reported, a patient was not involved and the event resulted in no adverse consequences reported.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Complaint history was reviewed and one similar complaint for this lot was identified.A non-conformance was initiated to investigate the root cause of this failure mode.Analysis of the device concluded that the set screw would never fit on the thread of any connector with this non-conforming condition.Therefore, this would always be detected by the user prior to locking of the rod to rod connector.Additional inspection of similar devices indicates this to be an event isolated to the devices captured in this event.

• Brand Name: AXIAL ROD CONNECTOR, OPEN-CLOSED; SIZE 5.5/6.0 - 5.5/6.0
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10404895
• Report Number: 3004774118-2020-00182
• Device Sequence Number: 19798323
• Product Code: NKB
• UDI-Device Identifier: 10888857039728
• UDI-Public: 10888857039728
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: Other
• Device Model Number: 2901-86055MF
• Device Catalogue Number: 2901-86055MF
• Device Lot Number: EJVX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1