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	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been discarded.
Event or Problem Description
It was reported that the tip of an es2 k-wire snapped off during screw insertion.The broken piece was removed and surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.
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, no similar complaints were identified.The device stg was reviewed and the following was identified: k-wire management 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.Note: the k-wire has 10mm increment markings to be used for reference to determine the depth of the instruments in the pedicle.Note: cantilevering the awl and taps while in the pedicle may damage the k-wire.Due to no product return or imaging of failure mode a root cause could not be determined conclusively.Cantilevering awl and taps can damage the k-wire and subsequently effect screw insertion.
Event or Problem Description
It was reported that the tip of an es2 k-wire snapped off during screw insertion.The broken piece was removed and surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.

• 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): 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: 13349158
• Report Number: 0009617544-2022-00006
• Device Sequence Number: 1675471
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: 07613327096200
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/10/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 05/10/2022
• 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