MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PREP IM ENCHANCE TOTAL HIP KIT; CEMENT OBTURATOR

Catalog Number	121010
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the medical device packaging of three (3) prep im enchance total hip kit was found damaged in its storage box, with the double packaging broken and therefore unusable.As this was noticed in a non-surgical environment, there was no patient involved.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the associated devices packages were returned and evaluated.A visual inspection of the returned kits reveal damage to the packaging.A review made by the quality engineering team concluded that a single root cause could not be determined.However, this issue is not a systemic error, since it would have been caused by either a manual operations process or a post manufacturing handling error.Therefore, there is no reason to believe other parts are affected outside of the parts contained within this complaint event.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.A review of complaint history revealed similar events for the listed devices over 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 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 these products and event.According to the packaging sequence, the component should be place in the appropriate cavities in inner tray, seal tyvek lid to inner tray and fold peel flap under flange, the inner tray should be place into outer tray and seal.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: PREP IM ENCHANCE TOTAL HIP KIT
• Common Device Name: CEMENT OBTURATOR
• 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: 17986142
• Report Number: 1020279-2023-02027
• Device Sequence Number: 8167043
• Product Code: LZN
• UDI-Device Identifier: 03596010457127
• UDI-Public: 03596010457127
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K791125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 121010
• Device Lot Number: 22LSM0619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown