MAUDE Adverse Event Report: DEPUY SPINE INC 1.37MM GUIDEWIRE, BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	286705200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Local Reaction (2035); Not Applicable (3189)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported surgeon was placing screw over guidewire.Upon removing guidewire, the tip of the guidewire broke off into the vertebral body.Additional information received 13feb2018: the tip was not able to be retrieved.

• Brand Name: 1.37MM GUIDEWIRE, BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7270867
• Report Number: 1526439-2018-50144
• Device Sequence Number: 13926541
• Product Code: LXH
• UDI-Device Identifier: 10705034213668
• UDI-Public: 10705034213668
• Combination Product (Y/N): N
• Initial Reporter State: KY
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/30/2018

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 Catalogue Number: 286705200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR