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

Catalog Number	71362279
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal reference: (b)(4).H3, h6: the associated device was returned and evaluated.A inspection revealed that the device is bent.Also, it was found that the tip of the device is fractured off.The bending and fractures are related and might have happened because of use.A review of complaint history based on the historical data revealed 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.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode. 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.  .
Event or Problem Description
It was reported that, during surgery, two (1) reamer handle was noticed to be bent through regular use of product.Replacement requested.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.As per investigation results, it was found that the tip of the reamer handle device is fractured off.

• Brand Name: REAMER HANDLE
• Common Device Name: 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: 18398490
• Report Number: 1020279-2023-02610
• Device Sequence Number: 14154334
• Product Code: JDG
• UDI-Device Identifier: 03596010456519
• UDI-Public: 03596010456519
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71362279
• Device Lot Number: 14FM09094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown