MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC MICA BURR 2 X 12MM STERILE MICA; BURR, ORTHOPEDIC

Model Number	57SR0212
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "indeed, the drill is not effective on a very hard bone and causes burns of the skin even in normal condition after 2 minutes of use which may require the excision of the skin".
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded.
Event or Problem Description
It was reported that "indeed, the drill is not effective on a very hard bone and causes burns of the skin even in normal condition after 2 minutes of use which may require the excision of the skin".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The operative technique instructs user that: ¿burrs were designed to be used at 6000 rpm.Higher rotation could cause increased risk of bone necrosis or soft tissue damage.It is important to rotate and lift while cutting to both prevent any thermal injury to the skin/soft tissues and prevent plantar extension of the osteotomy on the near cortex.Imagine the skin portal as the fulcrum point for rotation.¿ 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.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: MICA BURR 2 X 12MM STERILE MICA
• Common Device Name: BURR, ORTHOPEDIC
• 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: 15130093
• Report Number: 3010667733-2022-00261
• Device Sequence Number: 12167103
• Product Code: HTT
• UDI-Device Identifier: 00889797067683
• UDI-Public: 00889797067683
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 57SR0212
• Device Catalogue Number: 57SR0212
• Device Lot Number: 1677518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown