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

Model Number	71355094
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery while reaming the femoral canal with the redapt reamer quick connect it was difficult to disengage it from the reamer.Surgeon used a hammer to tap the sleeve of the quick connect to disengage the devices.The outer sleeve was completely seized and would not translate back and forth.A delay of less than 30 min was reported.S & n back up was available to complete the procedure.No injuries or other complications were reported at this time.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 device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that this case reports that during the procedure, the quick connect handle was unable to disengage from the reamer.The surgeon eventually disengaged it by tapping the sleeve of the quick connect with a hammer.Per complaint details, there was a delay of less than 30 minutes, and a backup device was available to complete the procedure.There are no patient injuries or other complications reported.Therefore, no further clinical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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 have no 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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Without the return of the actual product involved or product information, our investigation could not proceed.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.

• 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
• MDR Report Key: 10511481
• Report Number: 1020279-2020-04491
• Device Sequence Number: 3134687
• Product Code: JDG
• UDI-Device Identifier: 00885556223093
• UDI-Public: 00885556223093
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71355094
• Device Catalogue Number: 71355094
• Device Lot Number: 17CSC0029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention