MAUDE Adverse Event Report: STRYKER SPINE-US ES2 LE NITINIOL KWIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48280232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event where an es2 k-wire fractured intra-operatively.The fractured piece was removed and surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Visual inspection was performed and the device was found to be fractured approximately 10 mm from the distal tip.A high degree of deformation was observed adjacent to fracture.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history was reviewed and no similar complaints for the reported lot number were identified.From the es2 surgical technique as the awl or tap advances into the pedicle, the proximal end will move relative to the markings on the k-wire.If this does not occur during insertion, the procedure should be stopped and imaging should be used to verify the position of the k-wire in relation to the awl or tap.The k-wire has 10 mm increment markings to be used for reference to determine the depth of the instruments in the pedicle.Cantilevering the awl and taps while in the pedicle may damage the k-wire.Place the screw and polyaxial screwdriver over the k-wire or y-wire and advance through dilator 3 to the opening created in the pedicle.Drive the screw into the pedicle; remove the k-wire or y-wire when the tip of the screw reaches the end of the pedicle to prevent it from advancing.Deformation observed adjacent to the fracture indicates that the k-wire was most likely bent to nearly the point of fracture during tapping and/or screw insertion.Material analysis performed on device with similar failure mode concluded that fracture was due to bending ductile overload.The most likely cause of the reported event was determined to be due to excessive force and/or cantilevering of the instrument during tapping and/or screw insertion.
Event or Problem Description
This record is a consolidation of q4 2021 records summarized as a part of the fda voluntary malfunction summary reporting program.This report summarizes one malfunction event where an es2 k-wire fractured intra-operatively.The fractured piece was removed and the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: ES2 LE NITINIOL KWIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13366583
• Report Number: 0009617544-2022-00007
• Device Sequence Number: 5353756
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: 07613327096200
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 48280232
• Device Catalogue Number: 48280232
• Device Lot Number: B74896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown