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

Model Number	71355094
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that before surgery, the redapt reamer quick connect was noticed to be contaminated with blood.Backup device from smith and nephew was available and no delay or injury occurred due to this event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has foreign debris on the exterior surfaces rendering the device inoperable.The device shows signs of extensive use.A review of complaint history did reveal one additional complaint for the listed batch for the same failure mode.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of 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 for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device revealed foreign debris on the exterior surfaces rendering the device inoperable.The device shows signs of extensive use.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review concluded that a similar event was identified, and it was determined that the root cause was related to the design of the instrument and human factors.However, s+n did not specifically inform the customer that this particular device has challenging features, and the cleaning personnel may have not been trained adequately on the s+n cleaning process.The device design was improved to incorporate slotted holes in the sleeve to allow for bioburden drainage.Additionally, the slots allow increased visibility of bioburden within the device¿s challenging feature - communicating to the cleaning personnel that the device should be cleaned appropriately.The listed batch was manufactured before corrective action implementation.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Corrective and preventive actions previously initiated.Should 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: REDAPT REAMER QUICK CONNECT
• 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: 11097570
• Report Number: 1020279-2020-08061
• Device Sequence Number: 19912076
• Product Code: JDG
• UDI-Device Identifier: 00885556223093
• UDI-Public: 00885556223093
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2025

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: 71355094
• Device Catalogue Number: 71355094
• Device Lot Number: 19KSC0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 06/28/2021; Not provided
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 06/29/2021; 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• 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 Sex: Unknown