MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY SLAP HAMMER EXTRACT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	74012451
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during tka surgery, a journey slap hammer extract broke while removing the cutting block from the patient (inside the patient).It is unknown whether the broken pieces entered the patient or not and how were they retrieved.No significant surgical delay was reported and the procedure was concluded with a smith and nephew backup device.No patient injury was reported.
Event or Problem Description
It was reported that, during tka surgery, a journey slap hammer extract broke while removing the cutting block from the patient (inside the patient).It was confirmed that pieces fell into the patient, and they were all retrieved using forceps.No significant surgical delay was reported, and the procedure was concluded with a smith and nephew backup device.No patient injury was reported.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured along the threads connecting the rod to the extractor block, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that per the complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Based on the information, the broken pieces were retrieved from inside of the patient using forceps.Since there was no significant surgical delay, the procedure was completed with a smith and nephew backup device and there was no patient injury, no further clinical/medical assessment is warranted at this time.Should any relevant clinical/medical assessment be provided, this complaint would be re-assessed.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY SLAP HAMMER EXTRACT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11820412
• Report Number: 1020279-2021-04224
• Device Sequence Number: 3792854
• Product Code: HRY
• UDI-Device Identifier: 03596010556752
• UDI-Public: 03596010556752
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: 74012451
• Device Catalogue Number: 74012451
• Device Lot Number: 08JM07719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 08/02/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 05/26/2021; 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention