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

Model Number	48280233
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	07/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; k-wire broke 3 times while trying to be removed as screw was being inserted.Surgeon uses a kocher if wire seems to be stuck, while grabbing the wire and twisting the wire it snapped.Additional information noted; all fragments were retrieved.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.No relevant manufacturing issues were identified as all units met stryker specifications.The root cause of the event is determined to be user error- incorrect alignment of the k wire and screw path causing pinching of the wire and leading to fracture.
Event or Problem Description
It was reported that; k-wire broke 3 times while trying to be removed as screw was being inserted.Surgeon uses a kocher if wire seems to be stuck, while grabbing the wire and twisting the wire it snapped.Additional information noted; all fragments were retrieved.

• Brand Name: ES2 LE NITINIOL KWIRE SHARP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6760062
• Report Number: 0009617544-2017-00299
• Device Sequence Number: 10968175
• Product Code: LXH
• UDI-Device Identifier: 07613327266450
• UDI-Public: (01)07613327266450
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 10/25/2017

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 Model Number: 48280233
• Device Catalogue Number: 48280233
• Device Lot Number: B74500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1