MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RDCE FRCPS W/ PTS BRD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71173377

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/25/2020

Event Type  Injury  

Event Description

It was reported that during surgery the device tip broke while reducing the fracture.The piece was retrieved, and the patient was not harmed.It is unknown if there was any delay or how was the procedure finished.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The visual inspection of the returned device confirms that the jaw of the tip of the forcep is broken off.The broken piece was not returned with the device.The device was manufactured in 2019.The device shows significant signs of wear/usage.A medical investigation was conducted and confirms per report the broken tip was retrieved and no harm to the patient occurred due to the breakage.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A complaint history review found related failures; 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.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.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.Case-2020-00008162-1.

• Brand Name: RDCE FRCPS W/ PTS BRD
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10297651
• MDR Text Key: 199553530
• Report Number: 1020279-2020-03348
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010519535
• UDI-Public: 03596010519535
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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
• Device Operator: Health Professional
• Device Model Number: 71173377
• Device Catalogue Number: 71173377
• Device Lot Number: 19LTCD147
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention