MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL19H L 399MM; PLATE, FIXATION, BONE

Model Number	71800019
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during procedure the packaging of the 4.5mm l-d fem lk pl19h l 399mm was found split and the sterile barrier was compromised.It was noted prior to giving it to the scrub nurse, into the sterile field.There was a s&n back up device of the same configuration available to complete the procedure.There was no delay.No injuries involved.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.Per photos attached the packaging for the product does slightly look damaged and possibly torn at the ends.The product was manufactured in 2015.Some potential probable causes for this event could include packaging damage in transit or storage.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file.No deviations were identified during device history record review.Hence, at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: 4.5MM L-D FEM LK PL19H L 399MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11371605
• Report Number: 1020279-2021-01555
• Device Sequence Number: 3754292
• Product Code: HRS
• UDI-Device Identifier: 03596010520050
• UDI-Public: 03596010520050
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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 Expiration Date: 02/08/2025
• Device Model Number: 71800019
• Device Catalogue Number: 71800019
• Device Lot Number: 15BM07647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1