MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOX CHISEL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED,

Model Number 71440373

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a tka procedure, when performing the second box chisel cut, the box chisel got stuck in the guide.It is struck.This happened inside the patient, and a change in surgical technique was required.There was no delay and no harm to the patient.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

D4: expiration date added.H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection confirmed the box chisel shows nicks at the tip, which could cause the device not to function as intended.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.(b)(4).

• Brand Name: BOX CHISEL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11242862
• MDR Text Key: 229083064
• Report Number: 1020279-2021-00720
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556034965
• UDI-Public: 00885556034965
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440373
• Device Catalogue Number: 71440373
• Device Lot Number: 16CM08286
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention