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

Model Number 71440373

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/03/2021

Event Type  Injury  

Event Description

It was reported that, during a tka, a box chisel was bent on the end, this caused that extra removal of bone was required outside of the normal chiseling from the box chisel impaction.Surgery was resumed, without any significant delay, with the same device; therefore, patient was not harmed.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the chisel ¿appeared to be bent on the end¿ which resulted in incomplete bone removal.It was communicated that a sawblade was used to remove additional bone and no bone defect resulted from the event.No surgical delay or patient injury was reported, and per correspondence, the surgeon was satisfied with the outcome; however, the requested clinical documentation was not available.S+n recommends that all reusable instruments be routinely inspected for functionality/wear/damage and replaced as necessary.The patient impact beyond the reported bent device requiring use of a backup instrument (sawblade) would not be anticipated as reportedly the patient is ¿healthy¿ with satisfactory surgical outcome.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: BOX CHISEL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11864512
• MDR Text Key: 251987545
• Report Number: 1020279-2021-04604
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention