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

Catalog Number 71118200

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Event Description

It was reported that during surgery reamer shaft broke.No other vendor reamers were usable to complete reaming.Ultimately had to open a second portal in the tibia to complete reaming with competitor reamers.Nail was inserted via the super patella portal.Delay 30minutes-1 hour reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not 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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.

• Brand Name: FLEXIBLE SHAFT W/CIR CONNECTOR
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9426815
• MDR Text Key: 169719492
• Report Number: 1020279-2019-04313
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K121714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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 Expiration Date: 01/23/2021
• Device Catalogue Number: 71118200
• Device Lot Number: 11AM14310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1