MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVOLVE; 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP

Model Number	685.007
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
It was reported by a representative from (b)(6) that a k-wire tip broke and remains in patient at s1.

• Brand Name: REVOLVE
• Common Device Name: 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12221643
• Report Number: 3004142400-2021-00133
• Device Sequence Number: 4672235
• Product Code: LXH
• UDI-Device Identifier: 00849044072105
• UDI-Public: 00849044072105
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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: 685.007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other