MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW; NAIL, FIXATION, BONE

Model Number	71677100
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a trauma procedure on (b)(6) 2021, a trigen intertan lag screw has migrated laterally since (b)(6) 2021 - (b)(6) 2021.Upcoming revision surgery expected on (b)(6) 2021.The current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.However, photos of the radiographs confirmed that the device was found to be loosened within the patient, which required the event to be revised.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.The clinical/medical evaluation concluded that after a medical review of this case only four x-ray photos were received.Per the medical director¿s analysis, ¿the four undated pelvic x-rays provided note a pelvic fracture as well as a femoral shaft fracture, intertan nail and cerclage wires.It is noted that in the image demonstrating that the compression screw has backed out, the femoral fracture and pelvic fracture is persistent, and the nail remains intact.It is unknown the stability of the pelvis and the impact it may have to the femoral nail and compression screw.¿ according to the report, a revision surgery was performed on 03-dec-21 to address this event.Per a subsequent email, the single undated, unlabeled photo provided was of the screw removed during the revision.Based on the information provided the root cause of the compression screw back out cannot be confirmed nor could the patient¿s impact beyond the reported revision procedure.Therefore, no further clinical/medical assessment is warranted at this time.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device was found to be loose, a contribution of the device to the reported event could be corroborated.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, fit/sizing, lack of ingrowth, and traumatic injury.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW
• 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: 13080411
• Report Number: 1020279-2021-08831
• Device Sequence Number: 5984684
• Product Code: JDS
• UDI-Device Identifier: 03596010563323
• UDI-Public: 03596010563323
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71677100
• Device Catalogue Number: 71677100
• Device Lot Number: 21FT51172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female