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 08/09/2021

Event Type  Injury  

Event Description

It was reported that, during an internal fixation surgery, a flexible shaft w/cir connector broke while in use.Surgery was resumed, after a delay of 30 minutes or less, with a smith and nephew back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection confirms that the flexible reamer shaft fractured within the shaft via mechanical overload.If sufficient offset bending or torsional forces are applied to the reamer shaft during use that exceeds the strength of the material, a mechanical overload fracture can occur.This device shows significant signs of wear/usage.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.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.Expected wear/tear is likely the probable cause 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.

• 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: 12370828
• MDR Text Key: 268249433
• Report Number: 1020279-2021-06533
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 20CM23436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention