MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3MMX1000MM BALL TP GDE RD; PLATE, FIXATION, BONE

Model Number 71631626

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/21/2021

Event Type  malfunction  

Event Description

It was reported that, during surgery, it was noticed that 3mmx1000mm ball tp gde rd went through the sterile package.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Results of investigation: the associated device was returned and evaluated.A visual inspection was conducted and confirmed the 3mmx1000mm ball tp gde rd has an packaging issue.The device went through the sterile package.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.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.A contribution of the device to the reported event could be corroborated as the devices packaging was found to be compromised.Factors that could contribute to the reported event include damage during shipping and/or damage during storage.Based on this investigation, the need for corrective action is not indicated.This issue was evaluated through our internal quality process, and the packaging will be optimized to prevent this issue.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.Corrected data: d9, h6 (health effect - impact code).

• Brand Name: 3MMX1000MM BALL TP GDE RD
• Type of Device: PLATE, FIXATION, BONE
• 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: 12291559
• MDR Text Key: 265548570
• Report Number: 1020279-2021-06207
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010529107
• UDI-Public: 03596010529107
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71631626
• Device Catalogue Number: 71631626
• Device Lot Number: 20LSM0249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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