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

Model Number	48280232
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when the surgeon was inserting the pedicle screw to left, the k-wire was broken because the insertion angle of the screw was deviated.The screw was reinserted but the fragment of the wire (approx 50mm length) was remained to the patient.
Additional Manufacturer Narrative
Lot# b80983.Visual, dimensional and functional analysis could not be performed as the device was not returned.No relevant manufacturing issues were found.It is likely that the device fractured due to deviation of angle of the screw.
Event or Problem Description
It was reported that; when the surgeon was inserting the pedicle screw to left, the k-wire was broken because the insertion angle of the screw was deviated.The screw was reinserted but the fragment of the wire (approx 50mm length) was remained to the patient.

• 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: 6800031
• Report Number: 0009617544-2017-00322
• Device Sequence Number: 10797279
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: (01)07613327096200
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 48280232
• Device Catalogue Number: 48280232
• Device Lot Number: B80983
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1