MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM IMPACTOR ROD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71364011

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 08/27/2018

Event Type  malfunction  

Event Description

It was reported that during surgery threads were stripped trying to thread on a stem.No harm to the patient was recorded and there was no broken piece left in the patient.

Manufacturer Narrative

The affected device was returned and evaluated.A visual inspection of the stem rod impactor revealed that the threaded end of the impactor is bent and the threads are damaged.The device was returned with no parts missing.The threads can be damaged if sufficient side loads are transferred to the tip during stem impacting.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.The complaint history revealed no additional complaints for the associated batch.Additionally, a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This investigation could not verify or identify any evidence of product contribution to the reported problem.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: STEM IMPACTOR ROD
• 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: 7896289
• MDR Text Key: 120967174
• Report Number: 1020279-2018-01874
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010199270
• UDI-Public: 03596010199270
• 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: 10/30/2018

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 Catalogue Number: 71364011
• Device Lot Number: 17JM01374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1