MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSCILLATING BLADE 1.27MM NRW POWERPRO; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440367

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a tka surgery, the package of a oscillating blade 1.27mm nrw powerpro was broken.This happened before use in patient.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

The associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device confirmed the stated failure mode.The sealed package of the device was unsealed.It is uncertain how that event occurred as the surgery was stated to be performed without delay with the same device.This is a single-use device and should be disposed of after its first use.A review of complaint history did not reveal similar events for the listed device.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.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Some potential probable causes for this event could include packaging damage in transit or storage.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: OSCILLATING BLADE 1.27MM NRW POWERPRO
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12538220
• MDR Text Key: 273544123
• Report Number: 1020279-2021-07218
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010515735
• UDI-Public: 03596010515735
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440367
• Device Catalogue Number: 71440367
• Device Lot Number: 18HGR1146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1