MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEM HD/NECK IMPCTR RPMT TIP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71360484

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  Injury  

Event Description

It was reported that during thr, the fem hd/neck impctr rpmt tip cracked into multiple pieces while seating a femoral head onto a stem, inside the patient.It was use a smith and nephew back up device to complete the procedure.A delay of less than 30 minutes was reported.No injury to the patient reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.The visual inspection of the returned impactor tip confirms the tip broke into several pieces.All pieces were returned for evaluation.The device exhibits signs of extreme wear and use.A medical investigation was conducted and confirms without the requested clinical information, the reported impactor tip breakage could not be further assessed.The impactor tip is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The device was returned for evaluation and per report ¿all pieces were returned for evaluation,¿ indicating that no pieces were retained in the patient.The patient impact beyond the reported device breakage could not be definitively determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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: FEM HD/NECK IMPCTR RPMT TIP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11814394
• MDR Text Key: 250282491
• Report Number: 1020279-2021-04116
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556024362
• UDI-Public: 00885556024362
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71360484
• Device Catalogue Number: 71360484
• Device Lot Number: 18KEM0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention