MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7MM L-D FIBULA PL 8H L 82MM; PLATE, FIXATION, BONE

Catalog Number	72464708
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up or inspection for an internal fixation procedure, it was noticed that the box of one (1) evos 2.7mm l-d fibula pl 8h l 82mm was closed with its plastic, but the bag with the plate inside was unsealed.The procedure was performed, after a significant delay, with a s+n back-up device.Patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that it is not confirmed that the patient was under anesthesia when the delay occurred, and according to the packaging sequence, the polybag should not be sealed.The unsealed polybag (containing the product inside) is placed inside the nylon pouch and then the nylon pouch should be sealed.The nylon pouch is then placed in the carton.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.The package is conforming with our packaging sequence, therefore, no probable cause is deemed necessary for this event.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Section h10 comment was corrected.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that according to the packaging sequence, the polybag should not be sealed.The unsealed polybag (containing the product inside) is placed inside the nylon pouch and then the nylon pouch should be sealed.The nylon pouch is then placed in the carton.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.The package is conforming with our packaging sequence, therefore, no probable cause is deemed necessary for this event.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: EVOS 2.7MM L-D FIBULA PL 8H L 82MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 19576707
• Report Number: 1020279-2024-01210
• Device Sequence Number: 19847833
• Product Code: HRS
• UDI-Device Identifier: 00885556644805
• UDI-Public: 00885556644805
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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
• Device Catalogue Number: 72464708
• Device Lot Number: 20DM15390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 07/12/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/18/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown