MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 40MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645040
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after 7 weeks of intertan procedure, the right nail post operation, surgeon said the screw isn´t seated right.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is heavily worn with damaged threads.A dimensional inspection was attempted but the device was too damaged from use to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.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 have no 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 documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a poor insertion technique or procedural error.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.
Event or Problem Description
It was reported that, seven (7) weeks after an internal fixation surgery that used intertan, the trigen low profile screw 5.0mm x 40mm did not seat right.A revision surgery was performed to address this adverse event; the whole system was explanted.Patient outcome is unknown.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is heavily worn with damaged threads.A dimensional inspection was attempted but the device was too damaged from use to obtain accurate measurements.The clinical/medical evaluation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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 documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to surgical technique used, size of device 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 future complaints and investigate as necessary.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 40MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10463934
• Report Number: 1020279-2020-04270
• Device Sequence Number: 11401224
• Product Code: HSB
• UDI-Device Identifier: 00885556215791
• UDI-Public: 00885556215791
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2021

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: 71645040
• Device Catalogue Number: 71645040
• Device Lot Number: 19HM06589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 07/29/2021; 09/10/2021
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 07/30/2021; 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71675514, LN: 19EM12095; PN: 71678080, LN: 15HT57752; PN: 71800310, LN: 18FM16085
• Outcome Attributed to Adverse Event: Other