MAUDE Adverse Event Report: SMITH & NEPHEW, INC. THIN OSTEO BLD ROUND END 20MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71369420
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during inspection it was noticed that the box of the blade did not have the casing, and the plastic part of a thin osteo bld round end 20mm that makes it sterile, was found to be broken.Surgery was performed, without any delay, using a smith and nephew backup device.The patient was not involved at the time of the finding.
Additional Manufacturer Narrative
Results of investigation: the associated package was returned and evaluated.The visual inspection revealed that a piece of the plastic casing of the package is broken off.A review made by the quality engineering team revealed that the single-use sterile packaged osteotome was not placed correctly in the plastic tray, as agreed upon in the supplier¿s procedure.The pressure from the osteotome pushing against the plastic tray likely caused the sharp edge of the osteotome to break through the tray.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.According to the packaging sequence, the inner tray should be fully sealed with the device correctly placed inside.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.Factors that could contribute to the reported event include manufacturing process errors.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.Sample returned for analysis.

• Brand Name: THIN OSTEO BLD ROUND END 20MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 18070388
• Report Number: 1020279-2023-02142
• Device Sequence Number: 18040948
• Product Code: JDG
• UDI-Device Identifier: 03596010402950
• UDI-Public: 03596010402950
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K123598
• 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): 03/14/2024

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: 71369420
• Device Lot Number: 20JSY0063
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 11/04/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• 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