MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. MICA BURR 2 X 20MM STERILE MICA; BIT, DRILL

Model Number	57SR0220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not returned at this time but is anticipated.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the surgeon was performing his second chevron osteotomy for the day when the 2x20mm burr (indicated for a chevron osteotomy) broke.He had to used a second burr without removing the broken burr from the metatarsal.The second burr end up breaking as well.The surgeon was able to remove the two broken burrs from the bone by using a pair of forceps.After using an third 2x20mm burr the surgery was completed with no additional complications.The surgery was delayed by an hour additional anesthesia was required to complete the surgery.The surgeon noted that the patients bone was hard.
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned device is broken in two pieces.Examination of the returned device does confirm the burr has fractured.845 inches from the distal tip.The fracture surface is consistent with a fatigue fracture with ratcheting, which is indicative of excessive number of stress concentrations on the surface and/or extremely high stress.The break is at the point on the shaft where the diameter increases.This location is consistent with where a failure would occur if an overload force were applied during use.It could be due to hard bone or excessive bending during use, which is supported by the fact that two burrs broke during the same procedure.Based on investigation, the root cause was attributed to a user related issue.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by misuse of the devices and the application of mechanical overloads on them.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.
Event or Problem Description
It was reported that the surgeon was performing his second chevron osteotomy for the day when the the 2x20mm burr (indicated for a chevron osteotomy) broke.He had to used a second burr without removing the broken burr from the metatarsal.The second burr end up breaking as well.The surgeon was able to remove the two broken burrs from the bone by using a pair of forceps.After using an third 2x20mm burr the surgery was completed with no additional complications.The surgery was delayed by an hour additional anesthesia was required to complete the surgery.The surgeon noted that the patient's bone was hard.

• Brand Name: MICA BURR 2 X 20MM STERILE MICA
• Common Device Name: BIT, DRILL
• 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: 12318425
• Report Number: 0001043534-2021-00148
• Device Sequence Number: 3002064
• Product Code: HTW
• UDI-Device Identifier: 00889797067690
• UDI-Public: 00889797067690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 11/18/2021

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: 57SR0220
• Device Catalogue Number: 57SR0220
• Device Lot Number: 1676469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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