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

Model Number 71631626

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, when opening the box of a 3mmx1000mm ball tp gde rd during surgery, it was found the rod was sticking through the sterile package.The procedure was completed, without delay, using a s+n back-up device.Patient was not harmed.

Manufacturer Narrative

H10: additional information in d9.H3, h6.The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device¿s packaging was found to be punctured by the guide rod, rendering the device inoperative.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.According to the packaging sequence, the guide rod should be fully inserted into the foam end cap on both ends.The guide with the foams should be placed inside the pouch and sealed as close to the end cap as possible to prevent the detachment of end caps during transit.A new packaging upgrade is in progress, which will mitigate the occurrence of this type of failure.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.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: 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: 15210537
• MDR Text Key: 302125570
• Report Number: 1020279-2022-03634
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 21GSM0178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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