MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI Z HANDLE ACET REAMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71364073

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2020

Event Type  Injury  

Event Description

It was reported that while reaming the acetabulum, the reamer shaft broke at the connection to the reamer hand piece due to excessive force.The device broke during surgery, while inside the patient.Procedure was completed using a sn backup device.No delay or injury to the patient was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the u joint fractured on the inner portion of the device.All pieces were returned for evaluation.This device shows signs of significant wear/usage.A medical investigation was conducted and confirms the single photo provided confirm the reported failure.Based on the information provided the root cause of the device breakage was due to excessive force.The patient impact beyond the reported instrument breakage and possible retained foreign body of a non-implantable device could not be determined, although, corrosion/local irritation and possible migration of possible retained foreign body could not be ruled out.Per communications, the procedure was completed using a sn backup device.Since there was, no delay or injury to the patient, no further clinical/medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

Case (b)(4).Lot number and expiration date manufacture date.

• Brand Name: MI Z HANDLE ACET 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: 10652943
• MDR Text Key: 210521127
• Report Number: 1020279-2020-05277
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010507570
• UDI-Public: 03596010507570
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71364073
• Device Catalogue Number: 71364073
• Device Lot Number: 13HM19173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 09/11/2020; 05/20/2021
• Supplement Dates FDA Received: 05/05/2021; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention