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 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that the flexible shaft w/cir connector was found broken during inspection/set up, before a case.Not sure how it was broken.No delay or injury to the patient was reported.The procedure was completed using a backup device.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device is fractured, and the fractured piece was returned, rendering the device inoperable.The device was manufactured in 2011 and shows signs of extensive use.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.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.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: 11094861
• MDR Text Key: 224300967
• Report Number: 1020279-2020-08011
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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: 71118200
• Device Catalogue Number: 71118200
• Device Lot Number: 11KM03266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1