MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ONE-PIECE 14MM CHANNEL REAMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71631039

Device Problems Corroded (1131); Failure to Clean Adequately (4048)

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

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that trigen instruments cannot be reprocessed as they cannot be thoroughly cleaned and corrosion cannot be removed.As this was noticed in the sterilisation department, the finding did not affect any particular patient.

Manufacturer Narrative

After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that one-piece 14mm channel reamer instruments cannot be reprocessed as they cannot be thoroughly cleaned and corrosion cannot be removed.As this was noticed in the sterilization department, the finding did not affect any particular patient.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since there was not patient involvement; and therefore, there was no serious injury.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.

• Brand Name: ONE-PIECE 14MM CHANNEL REAMER
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12538192
• MDR Text Key: 273544934
• Report Number: 1020279-2021-07210
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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 Catalogue Number: 71631039
• Device Lot Number: 14ECT0002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1