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

Catalog Number 71364005

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during surgery the calcar reamer large was dull which caused a fracture to the calcar and had to use cables to fix.The procedure was resumed, after a non-significant delay and a change in surgical technique.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the device is dull.This device exhibit signs of significant wear and use.The clinical/medical evaluation concluded that as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Reportedly, during an unspecified surgery a large calcar reamer and a small calcar reamer were reportedly ¿dull which caused a fracture to the calcar.Per case details, the fracture was fixed using cables.The instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices directs to visually inspect for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.The procedure was reportedly resumed after a non-significant delay using in the surgical technique.In addition, 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.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.At this time, we do not have 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 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: CALCAR REAMER LARGE
• 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: 17957857
• MDR Text Key: 325950227
• Report Number: 1020279-2023-01982
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010199218
• UDI-Public: 03596010199218
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

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 Catalogue Number: 71364005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/17/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male