MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN LOW PROFILE SCREW 5.0MM X 70MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71645070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to the proximal screw was found broken.The revision surgery was not part of the postoperative plan.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis indicated that the screw fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the screw could not bear the imposed patient loading, which led to an overload fracture.Fatigue cracking is caused by cyclic (i.E.Repeated) stresses in excess of the material endurance limit for an extended period of time.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union, applications of loads in excess of the material¿s strength, and/or poor bone quality.No material or manufacturing defects were observed during this investigation.A clinical analysis indicated that based on the provided radiographs and the product evaluation, the root cause of the implant fracture was likely due to excessive patient activity prior to full bone union.The further impact to the patient beyond the revision cannot be concluded.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.A review of complaint history for the listed parts did not reveal additional complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GEN LOW PROFILE SCREW 5.0MM X 70MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7838882
• Report Number: 1020279-2018-01686
• Device Sequence Number: 13832331
• Product Code: HSB
• UDI-Device Identifier: 00885556216392
• UDI-Public: 00885556216392
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2019

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: 71645070
• Device Lot Number: 17GM03357
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 06/02/2019
• 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: 71648336 71645040 71645045 76518025; 71648336 71645040 71645045 76518025
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR