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

Catalog Number	121010
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, when a box of prep im enhance total hip kit was received in a care unit, the cardboard box was intact but the inside blister pack was defective.The outer and inner tray were both delivered broken off.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
Additional information: d9 & h3 (sample returned for analysis), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated device was returned and evaluated.The visual inspection revealed that the plastic tray that houses the hip kit is fractured on one corner and the sterility has been compromised.This inspection was conducted by the naked eye.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review made by the quality engineering team revealed that after reviewing the damages internally and with the supplier, it was concluded that the damage was caused by excessive handling.Since the report of this complaint, the sterilization supplier was changed.Furthermore, additional training will ensure that the proper palleting guidelines are being followed.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 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.According with packaging material specification, the purchasing requirements for a thermally preformed part consisting of polyethylene to produce or be used within a sterile barrier packaging assembly for the packaging of sterile medical products shall be met.At this time, we have no evidence to conclude that the trays failed to meet any specifications at the time of manufacture.The root cause of this event was determined to be handling damage during transport/ shipping.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: 18800573
• Report Number: 1020279-2024-00451
• Device Sequence Number: 7342575
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 23HSM0538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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