MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. MINI IGNITE; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	876P0400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available.
Event or Problem Description
It was reported that the jam shidi tip broke offin the patient's illiac crest while trying to take bma.The tip could not be removed from the patient.
Event or Problem Description
It was reported that the jam shidi tip broke offin the patient's illiac crest while trying to take bma.The tip could not be removed from the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and confirmed the allegation.The device inspection revealed the following: visual examination of the returned device does confirm the tip has fractured off at the second row of ports.The breakage appears to be oblique, which is typically indicative of levering of an instrument.Based on the investigation the root cause was attributed to a user related issue.The breakage of the tip most likely happened due to bending overload applied while the tip was inserted in the patient.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: MINI IGNITE
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12155515
• Report Number: 0001043534-2021-00116
• Device Sequence Number: 4777321
• Product Code: MQV
• UDI-Device Identifier: 00840420135162
• UDI-Public: 00840420135162
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K052913
• 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): 11/11/2021

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 Expiration Date: 01/23/2025
• Device Model Number: 876P0400
• Device Catalogue Number: 876P0400
• Device Lot Number: 1703343023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown