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

Model Number 71173377

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation. a visual inspection was performed and confirmed the forceps are bent at the tip. a review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 complaint history for the listed part revealed prior complaints for the listed failure mode with the same batch number.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.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Event Description

It was reported that, the clamp of a rdce frcps w/ pts brd was observed to be damaged (b)(4) and that the tip of a t8 linear driver shaft w/ ao qc is twisted (b)(4).It is unknown whether the event happened during surgery and if there was a patient involvement.During investigation approved on (b)(6) 2021 was confirmed that forceps are bent at the tip.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11931504
• MDR Text Key: 254063102
• Report Number: 1020279-2021-04971
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010519535
• UDI-Public: 03596010519535
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2021

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
• Device Operator: Health Professional
• Device Model Number: 71173377
• Device Catalogue Number: 71173377
• Device Lot Number: 20ETCD052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1