MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0 CANNULATED SCREW 2.5 HEX SST 34MM; SCREW, FIXATION, BONE

Catalog Number	71935423
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy, the cannulated screw lost the key locking with the screw, it appeared to have damaged the screw head.The procedure was completed with a surgical delay of 1 hour using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However an image evaluation was performed and found in the first image the screw with no visible defects.The second image shows the screw head which is deformed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H10: h2: additional information on: d4 (lot number & expiration date) & h4.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device finds the device returned with the formed indention in the proximal end ground out.An image evaluation was performed and found in the first image the screw with no visible defects.The second image shows the screw head which is deformed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (an application of unintended inappropriate or excessive force to the device).Based on this investigation, there is no evidence to suggest a design, material, or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: 4.0 CANNULATED SCREW 2.5 HEX SST 34MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19213284
• Report Number: 1219602-2024-00901
• Device Sequence Number: 15458055
• Product Code: HWC
• UDI-Device Identifier: 00885556650240
• UDI-Public: 00885556650240
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K210837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/28/2024

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: 71935423
• Device Lot Number: 22LPU0002A
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 10/09/2024; 11/27/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/13/2024; 10/14/2024; 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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 Age: 32 YR
• Patient Sex: Male