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

Model Number 71362279

Device Problems Material Deformation (2976); Mechanics Altered (2984)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: case(b)(4).

Event Description

It was reported that, during a thr surgery, one (1) reamer handle device broke at the connection point to the hudson adapter whilst reaming the acetabulum.The procedure was resumed, without any delay, using a s+n back up device.Patient was not injured as a consequence of this issue.

Event Description

It was reported that, during a thr surgery, (1) reamer handle device broke at the connection point to the hudson adapter whilst reaming the acetabulum.The procedure was resumed, without any delay, using a s+n back up device.Patient was not injured as a consequence of this issue.Additionally, further investigation of the returned device, noticed that the reamer handle is not broken but it has a bent spring.

Manufacturer Narrative

Additional information received by the manufacturer identified that this event should be re-evaluated for mdr reporting.The new information received confirmed that the spring of the reamer handle is bent and misshapen and not broken.The reassessment determined that the issue does not meet the threshold for reporting and therefore, it is a non-reportable event.If further details are provided, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: REAMER HANDLE
• 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: 15948720
• MDR Text Key: 308017613
• Report Number: 1020279-2022-04923
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010456519
• UDI-Public: 03596010456519
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71362279
• Device Catalogue Number: 71362279
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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