MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LCK TUBULAR PL 6H 82MM; PLATE, FIXATION, BONE

Catalog Number	71809006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a replacement surgery was performed due to the plate snapped in half.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Based on this investigation it was concluded that the locking tubular plate fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross section could not bear the imposed patient loading, which led to an overload fracture.Fatigue cracking is caused by the plate bearing cyclic stresses in excess of the material endurance limit for an extended period of time.These excessive cyclic stresses may be caused by any applications of loads in excess of the material¿s strength, or poor bone quality.No material or manufacturing deviations were observed during this investigation.The clinical/medical team concluded, it was reported that a revision was performed approximately 7 months post implantation due to a fractured tubular locking plate.There was no report of traumatic injury to the patient.There are no supporting clinical documents provided for inclusion in this investigation.However it was reported that there was a non-union of the fracture.Based on the analysis conducted of the returned product, it was determined that the plate 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 plate could not bear the imposed patient loading, which led to an overload fracture.Therefore due to insufficient information, a medical assessment is not able to be performed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.If new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: 3.5MM LCK TUBULAR PL 6H 82MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7251200
• Report Number: 1020279-2018-00132
• Device Sequence Number: 16364461
• Product Code: HRS
• UDI-Device Identifier: 03596010523211
• UDI-Public: 03596010523211
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K033669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/24/2018

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: 71809006
• Device Lot Number: 17DT86070
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/25/2018
• 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