MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 35MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during surgery, the left intertan nail and the single sliding trigen low profile screw were placed.The distal locking was performed in the hole and the trigen low profile screw stopped advancing approximately 7mm to reach the second cortex.The screw head separated and did not allow advancement.The physician decided to retrieve the fragment with an adjustable pressure forceps but screw head broke.The shaft of the screw was left inside the bone passing through the nail locking hole.The procedure was completed with the same device without significant delays.No further complications were reported.
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and revealed the device is broken.The clinical/medical investigation concluded that, the fluoroscopic images provided support to the initial breakage of the part the subtroc lag screwdriver that was removed.However, the distal screw breakage which was reported as retained is not visible in any of the provided images as the distal locking area of the nail is not within the image.Based on the limited information provided, the definitive clinical root cause of the reported breakage could not be determined.However, we cannot rule out a procedural variance as a likely contributory factor.The retained shaft of the trigen low profile screw is implantable, so biocompatibility is not an issue.Since the shaft of the screw was reported as retained inside of the patient¿s bone, micro-motion/migration is unlikely.According to the report, the procedure was completed with the same device without significant surgical delay and no other complications were reported.Therefore, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Verifying the device configuration according to the drawing print is within the steps of the final inspection.A review of material specification revealed that device materials quality are controlled during manufacture.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for intramedullary nail system revealed that fracture of the implant components has been identified as a possible adverse effect.Also, the indications section, establishes that the general principles of patient selection and sound surgical judgment apply to the intramedullary nailing procedure.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.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 poor insertion technique, surgical technique or user/procedural variance.As the device broke and a piece of it could not be removed from the patient, the contribution of the device to the adverse event could be corroborated.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.
Additional Manufacturer Narrative
H10: additional information in b5.
Event or Problem Description
It was reported that, during surgery, the left intertan nail and the single sliding trigen low profile screw were placed.The distal locking was performed in the hole and the trigen low profile screw stopped advancing approximately 7mm to reach the second cortex.The screw head separated and did not allow advancement.The physician decided to retrieve the fragment with an adjustable pressure forceps but screw head broke.The shaft of the screw was left inside the cortex of the left proximal femur passing through the nail locking hole.The procedure was completed with the same device without significant delays.No further complications were reported.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 35MM
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14670559
• Report Number: 1020279-2022-02910
• Device Sequence Number: 6633993
• Product Code: HSB
• UDI-Device Identifier: 00885556215692
• UDI-Public: 00885556215692
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K161264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2022

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: 71645035
• Device Catalogue Number: 71645035
• Device Lot Number: 19CM11306
• 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: 05/29/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 08/10/2022
• Initial Report FDA Received Date: 06/11/2022
• Supplement Report FDA Received Date: 07/08/2022; 08/12/2022
• Date Device Manufactured: 03/14/2019
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 50 KG