MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE SHAFT W/CIR CONNECTOR; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 71118200

Device Problem Break (1069)

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

Event Date 06/20/2021

Event Type  malfunction  

Event Description

It was reported that during a trauma procedure for a femur fracture, a flexible shaft w/cir connector broke, no pieces were lost in the patient.Procedure was completed with a back up device, no surgical delay reported.Patient was not harmed as a consequence.

Event Description

It was reported that, during a trauma procedure for a femur fracture, a flexible shaft w/cir connector broke outside, no pieces were lost in the patient.Procedure was completed with a back up device, no surgical delay reported.Patient was not harmed as a consequence.

Manufacturer Narrative

Section b5 and d8 were updated with new information.Internal complaint reference number: case-(b)(4).Section h1 was corrected due to the new information received.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The head of the device that attaches to the corresponding device is broken, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical investigation concluded that per subsequent e-mail no relevant clinical information will be provided for inclusion in this medical investigation.Based on the information provided, the flexible shaft w/cir connector broke outside of the patient, therefore, no pieces were left inside of the patient.It was reported, the procedure was completed with a backup device without a surgical delay.Since there was no alleged harm to the patient, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint would be re-assessed.A review of complaint history did reveal additional complaints for the listed batch.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.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 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.

• Brand Name: FLEXIBLE SHAFT W/CIR CONNECTOR
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12119159
• MDR Text Key: 260020674
• Report Number: 1020279-2021-05710
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03596010436528
• UDI-Public: 03596010436528
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2021

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: 71118200
• Device Catalogue Number: 71118200
• Device Lot Number: 16CM06593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 06/29/2021; 07/19/2021
• Supplement Dates FDA Received: 07/09/2021; 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention