MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE DRILL 35MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71362935
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during set up or inspection for a thr, the package one (1) flexible drill 35mm seemed perfect but when it was opened, the protective inner package was broken and compromised.The procedure was performed, without any delay, using a s+n back-up device.Since incident occurred before procedure; patient was not yet involved.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the photograph was reviewed, and revealed that the packaging of the device is opened.A review made by the quality engineering team revealed that factors that could have cause this is damage during transit.As of november 11th, of 2023 the packaging configuration for this product line was changed.The carting was made larger and the plastic tray was removed from the configuration and instead a polyurethane sleeve is in place of the plastic tray.These packaging changes have fully addressed this issue and no further actions are required.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 historical review concluded that there are no prior actions related to this product and event.According to the packaging sequence, the device should be placed in the lid and the lid should not have any damage.Also the purchasing requirements for a preformed lid stock, to produce a sterile barrier packaging assembly for the packaging of sterile medical products is covered in material specification.At this time, we have no evidence to conclude 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 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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device reveals the protective inner packaging has some pieces broken off.The piece of the packaging was found inside the outer box.This inspection was conducted by naked eye.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that the factor that could have cause this event was determined to be damage during transit.As of november 11th, of 2023 the packaging configuration for this product line was changed.The carting was made larger and the plastic tray was removed from the configuration and instead a polyurethane sleeve is in place of the plastic tray.These packaging changes have fully addressed this issue and no further actions are required.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 device should be placed in the lid and the lid should not have any damage.Also the purchasing requirements for a preformed lid stock, to produce a sterile barrier packaging assembly for the packaging of sterile medical products is covered in the material specification.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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: FLEXIBLE DRILL 35MM
• 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: 18888458
• Report Number: 1020279-2024-00523
• Device Sequence Number: 18086148
• Product Code: JDG
• UDI-Device Identifier: 03596010464668
• UDI-Public: 03596010464668
• Combination Product (Y/N): N
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 71362935
• Device Lot Number: 23HSC0030
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 09/19/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 07/10/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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