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

Model Number 71631626

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

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

Event Date 02/16/2023

Event Type  malfunction  

Event Description

It was reported that, during the set up and inspection for an unknown surgery, it was noticed that the package of a 3mmx1000mm ball tp gde rd was not feeling sealed when opened.It is unknown how the procedure was finished.No patient injuries or surgery delays were reported.

Manufacturer Narrative

Internal complaint reference: case(b)(4).

Manufacturer Narrative

H3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Material specification, covers the requirements for a preformed pouch consisting of heat seal coated dupont 1073b tyvek heat sealed to polyethylene/polyester film, to produce a sterile barrier packaging assembly for the packaging of sterile medical products.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include damage during shipping and/or mishandling.Based on this investigation, the need for corrective action is not indicated.Should the device or 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: 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: 16554310
• MDR Text Key: 312006532
• Report Number: 1020279-2023-00553
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010529107
• UDI-Public: 03596010529107
• Combination Product (y/n): N
• PMA/PMN Number: K123055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: 21LNX0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1