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

Model Number 71118200

Device Problem Crack (1135)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

It was reported that a flexible shaft w/cir connector was noticed to be cracked on the shaft before case.No harm or injury reported on patient.Procedure was finished with a smith and nephew back up device.No delay reported.

Manufacturer Narrative

The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is cracked and has signs of wear and tear from use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/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 actions are being taken at this time.

• 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: 10841643
• MDR Text Key: 216306794
• Report Number: 1020279-2020-06458
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03596010436528
• UDI-Public: 03596010436528
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1