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

Catalog Number	48280232
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during a case with a neurosurgeon in a public hospital, 2 k-wires broke while inserting into the vertebral body through the jamshidi needle.The surgeon was holding the wires with a wire holder and impacting with a small mallet on the holder itself, no impaction was applied onto the wires itself.Both times the surgeon was able to withdraw the wires and insert another one to complete the procedure.
Additional Manufacturer Narrative
Risk assessment; the product was not returned as they were disposed and no lot#s were provided.Therefore, device evaluation, device history review and complaint history review could not be performed.The exact root cause cannot be determined conclusively.
Event or Problem Description
It was reported that; during a case with a neurosurgeon in a public hospital, 2 k-wires broke while inserting into the vertebral body through the jamshidi needle.The surgeon was holding the wires with a wire holder and impacting with a small mallet on the holder itself, no impaction was applied onto the wires itself.Both times the surgeon was able to withdraw the wires and insert another one to complete the procedure.

• Brand Name: ES2 LE NITINIOL KWIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6419462
• Report Number: 0009617544-2017-00105
• Device Sequence Number: 550442
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: (01)07613327096200
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: No Information
• Device Catalogue Number: 48280232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1