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

Model Number	71631130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, when milling the medullary canal, during the final milling, a flex reamer extender broke.Additionally, no fragment was left inside the patient.It remains unclear how the surgery was finished, however no delay or patient harm has been reported.
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during surgery, when milling the medullary canal, during the final milling, a flex reamer extender broke.Additionally, no fragment was left inside the patient.The procedure was successfully completed, using the same device.No delay or patient harm has been reported.
Additional Manufacturer Narrative
Additional information: b5-description.D4-lot number e1 (initial reporter name), h6 (health effect - impact code).
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.As the part and batch number information provided did not match into the system, therefore, a device history record review could not be performed.A review of complaint history did not reveal similar events for the listed device over the previous 12 months.The batch number provided is not valid within the system, though the review was performed and did not reveal similar events.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 there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any 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 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 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.

• Brand Name: FLEX REAMER EXTENDER
• 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: 17102354
• Report Number: 1020279-2023-01268
• Device Sequence Number: 11245779
• Product Code: JDG
• UDI-Device Identifier: 03596010419613
• UDI-Public: 03596010419613
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2023

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 Model Number: 71631130
• Device Catalogue Number: 71631130
• Device Lot Number: 17OM03019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 06/14/2023; 07/21/2023
• Initial Report FDA Received Date: 06/11/2023
• Supplement Report FDA Received Date: 06/19/2023; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male