MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM STR THREADED HNDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71362804

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2021

Event Type  Injury  

Event Description

It was reported that the tandem str threaded handle broke.The surgeon was trialing with a 52 head and it broke in his hand.While putting in the trial head.Nothing was left in the patient.It is unknown if there was a delay or how the procedure was finished.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of returned device confirms the tandem str threaded hndle has fractured into two pieces.Both pieces were returned.The device exhibit signs of significant wear and use.The device was manufactured in 2013.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TANDEM STR THREADED HNDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11321589
• MDR Text Key: 231602362
• Report Number: 1020279-2021-01176
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010497994
• UDI-Public: 03596010497994
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71362804
• Device Catalogue Number: 71362804
• Device Lot Number: 13LM08752
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention