MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN TRIGEN META-TAN TROCH ANTEGR NAIL SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNKNOWN

Device Problems Fracture (1260); Separation Failure (2547); Deformation Due to Compressive Stress (2889)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Foreign Body In Patient (2687)

Event Date 11/21/2022

Event Type  Injury  

Event Description

It was reported that, during a meta tan removal (pseudarthrosis, change from trg meta tan to t2a), when trying to remove the lag screw with a lag screw driver, the driver could not rotate and could not remove the lag screw.Then the connection part on the lag screw was broken.Furthermore, the doctor attempted to remove the lag screw using other device (referred as "easy out" without clear evidence of its identity), however, the tip of the device (easy out) was broken off and could not be retrieved.The doctor gave up with the removal of the nail; therefore, the metatan nail, the lag screw, one captured screw and the tip of easy out were left inside the patient.A surgical delay of 20 minutes occurred before deciding to cancel the procedure.It is unknown if an additional appointment has been scheduled to attempt the hardware removal and the "easy out" broken piece retrieval.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Section h3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, it was reported that, during a meta tan removal (pseudarthrosis, change from trg meta tan to t2a), when trying to remove the lag screw with a lag screw driver, the driver could not rotate and could not remove the lag screw and then the connection part on the lag screw experienced ¿physical breakage¿.Furthermore, the doctor reportedly attempted to remove the lag screw using a non-s+n "easy out" device ¿made in japan¿; however, the tip of the device (¿easy out¿) broke off and could not be retrieved.It is unknown if this tip is lodged in the bone, implant or other tissue.The doctor abandoned the removal of the nail; therefore, the meta tan nail, the lag screw, one captured screw and the tip of non-s+n ¿easy out¿ device were left inside the patient.Reportedly, a surgical delay of 20 minutes occurred before deciding to cancel the procedure.Per correspondence, ¿one capsular screw is left in the dynamization hole and postoperative weighting is used to attempt bony fusion¿.It was communicated that the requested clinical documentation was not available.Without the requested clinical documentation, there were no clinical factors assessed which would have contributed to the event.The patient impact beyond the reported pseudarthrosis, attempted revision to competitor nail, lag screw breakage, broken ¿easy out¿ tip/retained foreign body of unknown material, 20 minute surgical delay prior to procedure cancellation with the additional ¿postoperative weighting ¿used to attempt bony fusion¿ cannot be determined.No further medical assessment could be rendered at this time.Device specific identifiers were not provided thus an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions and product prints review could not be performed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.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.H6: health effect - clinical code, health effect - impact code and medical device problem code.

• Brand Name: UNKNOWN TRIGEN META-TAN TROCH ANTEGR NAIL SCREW
• Type of Device: 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: 15964762
• MDR Text Key: 305334129
• Report Number: 1020279-2022-04954
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention