MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD FLUSH CUTTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71360024

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/23/2021

Event Type  malfunction  

Event Description

It was reported that, during thr surgery it was noticed that the accord cable has the ¿cut this side¿ label on the wrong side of the cutter.It is unknown how the procedure was finished.No delay was reported.No other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.This is a training issue.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: ACCORD FLUSH CUTTER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11500228
• MDR Text Key: 240286348
• Report Number: 1020279-2021-02206
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010485397
• UDI-Public: 03596010485397
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 07/02/2021

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 Operator: Health Professional
• Device Model Number: 71360024
• Device Catalogue Number: 71360024
• Device Lot Number: 15CM03625
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1