MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI Z HANDLE ACET REAMER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71364073

Device Problem Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2018

Event Type  malfunction  

Event Description

Surgeon states offset reamer inner can no longer slide through outer sleeve.Smith and nephew backup was used.45 minute delay to procedure, no injury to patient.Device will be returned.

Manufacturer Narrative

The offset handle reamer was returned and evaluated.A visual inspection found no obvious signs of damage on the device.A functional inspection did find that the j-lock for the inner shell was difficult to engage.Additionally, the inner shell inserted into the outer shell with no problems.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review revealed 2 total complaints for the batch.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: MI Z HANDLE ACET REAMER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8171858
• MDR Text Key: 130623645
• Report Number: 1020279-2018-02813
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010507570
• UDI-Public: 03596010507570
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71364073
• Device Lot Number: 17HM03653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1