MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CHS LAG SC 80MM 3.15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	121105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a compression hip screw and plate inserted on (b)(6) 2019 to treat a fracture.On (b)(6) 2019, a revision surgery was performed to remove the implants, as the fracture had failed to heal.The surgeon was confident that there was no failure of the implant.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed to remove the implants, as the fracture had failed to heal.The affected classic chs plate, lag screw and four low profile self-tapping screws were returned for evaluation.The support plate 76515060 was not returned.A lab analysis conducted during this investigation indicated that a visual inspection showed corrosion on the surface of the chs plate.No other deviations were identified during this investigation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.It was communicated that the surgeon was confident that there was no failure of the implants.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: CHS LAG SC 80MM 3.15
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9079832
• Report Number: 1020279-2019-03415
• Device Sequence Number: 2529677
• Product Code: HSB
• UDI-Device Identifier: 03596010061805
• UDI-Public: 03596010061805
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2019

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 Catalogue Number: 121105
• Device Lot Number: 18AT97703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention