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

Catalog Number 71364073

Device Problem Break (1069)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that three (3) mi z handle acet reamer were broken at the base.The procedure was resumed, after a non-significant delay, with a s+n back-up device.No injury was reported as a consequence of this issue.

Manufacturer Narrative

Internal complaint number: (b)(4).

Manufacturer Narrative

H11: this complaint has been reassessed based on additional information gathered by the manufacturer.It was determined that this event does not fulfill reporting requirements per 21 cfr §803.The customer has confirmed that no broken pieces fell inside the patient.Further evaluation of the three returned devices have confirmed that the broken portions of the device consist of: 2 proximal power connectors which are used externally to the surgical site and 1 inner shaft breakage at a joint.The latter component is contained within an external housing that prevents fragments from entering the patient's incision.As such, there is no potential risk associated to these breakages.The procedure was able to be completed with a backup device without any impact to the patient or user.

• 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: 18637586
• MDR Text Key: 334652712
• Report Number: 1020279-2024-00279
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010507570
• UDI-Public: 03596010507570
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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 Catalogue Number: 71364073
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1