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

Model Number	48280233
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of an es2 k-wire fractured during surgery and was left in the patient's bone.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Device was discarded by hospital.
Event or Problem Description
A company representative reported that the tip of an es2 k-wire fractured during surgery and was left in the patient's bone.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.It was reported that the tip of an es2 k-wire fractured during surgery and the tip was left in the patient's bone.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.The es2 surgical technique was reviewed: "carefully determine the appropriate entry point and trajectory for the es2 screw.The entry point for percutaneous pedicle screws is approximately 4-5cm off mid-line with a more lateral trajectory." it is unknown if the k-wire was placed at a difficult angle or if a k-wire guide tube was used to insert the k-wire.Tip of the k-wire may have pinched while inserting awl/ screw, leading to increasing tension on the wire causing fracture."incorrect alignment of the k-wire and screw path may also cause pinching of the wire.".Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established with the information available.

• Brand Name: ES2 LE NITINIOL KWIRE SHARP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14042820
• Report Number: 0009617544-2022-00041
• Device Sequence Number: 6298317
• Product Code: LXH
• UDI-Device Identifier: 07613327266450
• UDI-Public: 07613327266450
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 48280233
• Device Catalogue Number: 48280233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown