MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS STEM DRIVER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71362631
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr two (2) cpcs stem drivers broke and did not lock into definitive stem.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.No pieces fell inside the wound.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
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.A visual/functional analysis has not revealed any deficiency with the reported device.The results of our investigation are provided as a courtesy.Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device did not reveal any pieces broken on or off the device.The device shows signs of normal wear and use.A functional evaluation reveals all components on the device are moving freely and as intended.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.No evidence on the alleged defects were found on the device, therefore no factors that can contribute the reported event can be delineated.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 a thr one (1) cpcs stem driver broke and did not lock into definitive stem.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.No pieces fell inside the wound.

• Brand Name: CPCS STEM DRIVER
• 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: 18322372
• Report Number: 1020279-2023-02498
• Device Sequence Number: 12602255
• Product Code: JDG
• UDI-Device Identifier: 03596010462879
• UDI-Public: 03596010462879
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71362631
• Device Lot Number: 21KM11593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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