MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX CAP SCREW 4.5MM X 35MM; NAIL, FIXATION, BONE

Model Number	71642135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during periprosthetic fracture reduction, a int hex cap screw 4.5mm x 35mm broke internal to patient.It is unknown if there was any delay nor injury reported.It is unknown if there was a s&n backup device available.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during periprosthetic fracture reduction, a int hex cap screw 4.5mm x 35mm broke internal during introduction in the femoral plate.The broken piece was kept inside the patient's femur and the screw head remained attached to the screwdriver.The procedure was completed without significant delays.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the reported event could be confirmed with the photos provided and reviewed in the clinical/medical evaluation.The clinical/medical investigation concluded that, two undated, unlabeled images were provided that show two fluoroscopic images provided confirms that a screw has broken.But the plate appears intact along with the cerclage cabling the fracture line as well in the provided image appears approximated.It¿s unknown the dates or how long implanted, the weight bearing status or compliance of the subject, or possible events which may have led to the broken screw or the initial fracture location to assess impact but based on the images provided we can confirm the event occurred.The retained int hex cap screw 4.5mm x 35mm is comprised of a biocompatible material which is intended for implantation.However, since the screw is unsecured outside of the bone we cannot rule the potential risk for micro-motion, migration, tissue inflammation and/or pain.According to the report, it is unknown if there was a delay, injury or if there was a s&n back-up device available.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this cause would be re-assessed.A review of the manufacturing records 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 review of the instructions for use documents for knee systems revealed that cracking or fracture of the implant components have been identified as possible adverse effects.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 with inspection drawing, the final inspection includes the verification of part configuration per print.Also, material specification shall control the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to fit/size of device, abnormal loadings applied to implant or surgical technique.The contribution of the device to the reported event could be corroborated since the screw broke as it is revealed in the images provided and evaluated by the clinical/medical team.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.B1, b2, b5.
Additional Manufacturer Narrative
Section h4 and d4 were updated due to new information received.

• Brand Name: INT HEX CAP SCREW 4.5MM X 35MM
• Common Device Name: NAIL, 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: 15037714
• Report Number: 1020279-2022-03316
• Device Sequence Number: 6943619
• Product Code: JDS
• UDI-Device Identifier: 03596010478894
• UDI-Public: 03596010478894
• Combination Product (Y/N): N
• Initial Reporter Country: AC
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (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): 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71642135
• Device Catalogue Number: 71642135
• Device Lot Number: 21JM00596
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 06/22/2022; 09/16/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/18/2022; 09/13/2022; 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown