MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 5 X 36 SELFTAP CAN SCR TI; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71755036
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a mislabeling issue with the 5 x 36 selftap can screw titanium.The chart stick label was from size 5x36 when packaging was 5x35 mm.It cannot be known at the moment what size was actually in the box, as the screw was used in the patient anyway.
Additional Manufacturer Narrative
Results of investigation: due to the nature of the alleged incident, the associated device was not returned for evaluation.The images provided were reviewed and the specifications from the chart stick labels in one image are different from the ones in the box of the second one.However a quality assessment was performed, and a packaging problem could not be confirmed.This investigation concluded that packaging is unable to print this specific discrepancy due to the age of the order and all labels are verified by packaging to ensure that labels are correct.Furthermore, a review of the distribution was conducted and reveled that switzerland received both batches, therefore, it can be concluded that this issue did not occur during the manufacturing process.A review of complaint history for the part numbers over the past 24 months and for the batches based on historical data did not reveal similar events.A review of the manufacturing records was performed and as they contained the correct labels for the products, it did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.An historical review concluded that there are no prior actions related to this product and event.According to the label specification, the packaging label should be for size 5x36, as well as the chart stick label.Possible causes could include but are not limited to mishandling during surgery set up.As the device was used in the patient, the contribution of the device to the reported event could not be corroborated.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: 5 X 36 SELFTAP CAN SCR TI
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10719270
• Report Number: 1020279-2020-05645
• Device Sequence Number: 3501097
• Product Code: HSB
• UDI-Device Identifier: 03596010500076
• UDI-Public: 03596010500076
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K032722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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 Model Number: 71755036
• Device Catalogue Number: 71755036
• Device Lot Number: 19HB00337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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