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

Model Number	57SR0220
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the wrong size burr was in the package.The customer does not know what size was in the package as they immediately disposed of this.
Additional Manufacturer Narrative
Device will not be returned since the device has been discarded.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
Please note corrections to the fda registration number.The mdr was submitted with 0001043534 and should have been reported under 3010667733 registration number: the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of available stock found no other units from this lot to inspect.A complaint history review found no other similar reports for this catalog/lot combo.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It is reported that the wrong size burr was in the package.The customer does not know what size was in the package as they immediately disposed of this.

• Brand Name: MICA BURR 2 X 20MM STERILE MICA
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15260205
• Report Number: 0001043534-2022-00001
• Device Sequence Number: 5787077
• Product Code: HTW
• UDI-Device Identifier: 00889797067690
• UDI-Public: 00889797067690
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/01/2022

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: 1676468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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