MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REPAIR, 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 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a bilateral tha surgery, while reaming the left leg, rotation of the minimal incision z handle acetabular reamer did not rotate properly.Therefore, when disassembled, the internal part was found to be broken.Surgery was resumed, after a non-significant delay, with a back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H6: the device was not returned for evaluation but the pictures were reviewed, and the broken device was confirmed.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.The anticipated risk level is still adequate.A historical review concluded that this event was previously identified and addressed through a supplier change.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.The contribution of the device to the reported event could be corroborated, since the device broke, therefore, it can not function properly anymore.Based on this investigation, the need for corrective action is not indicated.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.

Manufacturer Narrative

D4, h4: part and lot number, manufacture and expiration dates updated.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the inner portion broke into two pieces, rendering the device inoperable.All pieces of the device were returned.The device shows signs of significant wear and use.A functional evaluation revealed due to the break of the inner portion, the device will not work as intended.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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: REPAIR, 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: 14237101
• MDR Text Key: 290294477
• Report Number: 1020279-2022-02031
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010507570
• UDI-Public: 03596010507570
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2023

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: 14CM13033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 05/11/2022; 06/09/2022; 03/07/2023
• Supplement Dates FDA Received: 05/12/2022; 06/13/2022; 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 80 KG