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

Model Number 71364073

Device Problems Break (1069); Mechanics Altered (2984)

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

Event Date 03/27/2023

Event Type  malfunction  

Event Description

It was reported that, during a thr, the internal mechanism of one (1) mi z handle acet reamer broke during reaming.No pieces fell into the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the inner shaft broke into two pieces.All pieces of the device were returned.The device shows signs of significant wear and use.A review of complaint history based on the historical data revealed a similar events for the listed batch, 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that a similar event was previously identified, and prior actions were performed.In addition, it has been concluded that there is a potential for breakage if used after the expected lifetime or excessive force is used as this device is a reusable instrument and it is expected to wear over time.Also, the failure rate of this issue is within expected and documented in the risk file.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16781930
• MDR Text Key: 313743058
• Report Number: 1020279-2023-00888
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010507570
• UDI-Public: 03596010507570
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

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: 71364073
• Device Catalogue Number: 71364073
• Device Lot Number: 21KM08735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1