MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIBIAL DRILL WITH STOP; BIT, DRILL

Catalog Number	74036161
Medical Device Problem Codes	Fracture (1260); Failure to Cut (2587); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that during tka surgery, the tibial drill with stop is not drilling/cutting through bone adequately.According to the picture attached, the devices is fractured.The procedure had been completed, without any delay, using the same device.Patient was not harmed as consequence of this problem.
Event or Problem Description
It was reported that during tka surgery, the tibial drill with stop is not drilling/cutting through bone adequately.According to the picture attached, the device is deformed.The procedure had been completed, without any delay, using the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting.There is no evidence that indicates that an instrument fracture has occurred.Based on the picture provided, the tip of the reported tibial drill is deformed.This event may result in a short procedural delay and/or require use of a back-up device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable pursuant to applicable regulations.H11- corrected data.B5- describe event or problem.H6- evaluation codes: medical device problem code.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Event may result in a short procedural delay and/or require system re-boot or use of a backup device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable pursuant to applicable regulations.

• Brand Name: TIBIAL DRILL WITH STOP
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19483277
• Report Number: 1020279-2024-01089
• Device Sequence Number: 7924000
• Product Code: HTW
• UDI-Device Identifier: 00885556703649
• UDI-Public: 00885556703649
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2024

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
• Device Catalogue Number: 74036161
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/25/2024; 06/25/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/27/2024; 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown