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

Model Number 57SR0212

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 05/17/2022

Event Type  Injury  

Event 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".

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded.

Event 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".

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
• Type of Device: 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
• MDR Text Key: 296884870
• Report Number: 3010667733-2022-00261
• Device Sequence Number: 1
• Product Code: HTT
• UDI-Device Identifier: 00889797067683
• UDI-Public: 00889797067683
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention