MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD LG 30 DEG CBL OFF PSR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71360019

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2020

Event Type  malfunction  

Event Description

It was reported that in a accord lg 30 deg cbl off psr, the handle broke when they were trying to pass the cable round the bone.They were treating a peripostatetic fracture.This occurred during use ¿ instrument inside patient.It is unknown how was the procedure finished.No harm or injury reported on patient.No delay reported.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the limited information provided, the root cause of the handle breakage cannot be determined.The handle external to the surgical site so it¿s not likely that it was left within the patient, but it was not reported if there were any fragments and if all was removed.The handle is comprised of medical grade plastic not approved for long term implantation.Therefore, the future impact to the patient beyond the reported periprosthetic fracture and the potential for micro/migration and local tissue irritation of the retained piece of the handle cannot be determined.It is unknown how was the procedure completed.Since there was no reported delay or injury to this patient, 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 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.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ACCORD LG 30 DEG CBL OFF PSR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10879958
• MDR Text Key: 217625264
• Report Number: 1020279-2020-06616
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010500236
• UDI-Public: 03596010500236
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

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: 71360019
• Device Catalogue Number: 71360019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention